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  • Posted: Jul 29, 2023
    Deadline: Not specified
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    Aspen has a proud heritage dating back more than 160 years and is committed to sustaining life and promoting healthcare through increasing access to its high quality affordable medicines and products. Aspen has a market capitalisation of approximately US$10 billion, is the largest pharmaceutical company listed on the JSE Limited (share code: APN) and rank...
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    Process Pharmacist (Port Elizabeth)

    Main Purpose of the Role

    •  To ensure GDP and GWP compliance for all Warehouse and Distribution processes. Monitor adherence to guidelines, procedures and document controls. Deliver expected quality assurance and operational targets as per the business requirements. Assume pharmaceutical responsibility for warehouse processes. Serve as the deputy Responsible Pharmacist.

    Key Responsibilities:

    • Control of Schedule 5 and Schedule 6 items in accordance with legislative requirements
    • Control of fridge line items in accordance with legislative requirements
    • Manage and Control the Credit Returns processes
    • Manage and Control the destruction process
    • Perform internal and external audits; self-inspections, when required
    • Log CAPA’s, Deviations and Change controls
    • Assist with temperature monitoring and investigations
    • Review and update SOPS to ensure alignment to current business practices.
    • Conduct training of staff and maintain training records where applicable
    • Inspect and report on all Product Quality Complaints
    • Assist with investigation of Customer Complaints
    • Assist with the Blocking/unblocking of stock
    • Assist with Sample requests
    • Co-ordinate and monitor QA stock releases and re-blocking when required
    • Facilitate the return, control and reconcile of all Recalled stock
    • Facilitate the correct investigation and reporting of all stock non-conformances
    • Control and close out all non-conforming stock queries
    • Manage and control short dated/expired stock throughout the warehouse until destruction
    • Control the receipt and reporting of all warehouse damages
    • Ensure measures in place that prevent unauthorized access to stock
    • Assist with Quality Risk assessments when required
    • Identify storage requirement of stock and ensure data is updated on SAP
    • Ensure comprehensive investigations and reporting for all stock discrepancies and inventory adjustments made
    • Assist with stock audit trail reports for various departments
    • Assist with Customer verification
    • Manage and control export orders
    • Manage departmental SAP queries related to releases and Customer returns

    Requirements

    QUALIFICATIONS & EXPERIENCE:

    • BPharm degree
    • Registration with Pharmacy Council
    • 2- 5 years related work experience in industrial sector
    • Pharmaceutical Distribution experience would be an advantage.

     KNOWLEDGE

    • Knowledge of Regulatory and Pharmaceutical requirements, GMP, Product and Process knowledge

    SKILLS AND COMPETENCIES

    • Attention to detail; sense of urgency; accuracy and well organised
    • Good Interpersonal and communication skills
    • Analytical and good problem-solving skills
    • Demonstrate good leadership skills
    • Knowledge of Regulatory and Pharmaceutical requirements, GMP, Product and Process knowledge
    • Gathering of information
    • Meeting deadlines

    go to method of application »

    Pharmacovigilance Scientist (JHB North)

    OBJECTIVE

    • To support the SA Commercial Business to realize the commercial strategy and to achieve the annual targeted growth and revenue through successful new product introductions and maintenance of current product portfolio in the South Africa and South African Development Community (SADC) region, by ensuring successful Marketing Authorisation and variation approval from the SAHPRA and Regulatory Authorities of the SADC member states within the committed timeframe. The role undertakes responsibility for compliance with the Regulatory / Pharmacovigilance Requirements for the New Product Launch Pipeline and the existing product portfolio in the region, through the successful completion of assigned activities according to the South African and SADC Regulatory plan. To provide support to the Pharmacovigilance Lead for the various Pharmacovigilance operations, in particular the medical and scientific functions with respect to safety evaluations of all Aspen products across Pharmacare and any other entity owned by Aspen, of the Aspen Group for which marketing authorizations are held. The role undertakes responsibility for coordinating and management of review and analysis of aggregate safety data concerning the Aspen Group product portfolio.

    KEY RESPONSIBILITIES

    Key Accountabilities

    • Delegated tasks from RA Manager or PV Lead on a defined and ad hoc basis with the flexibility of mind-set and time resource this entails. This will include representation at meetings when required.
    • Functional reporting: Mentoring of the Pharmacovigilance Officers and Medical Writers.
    • Review and advice regarding relevant local and global guidelines, policies, internal procedures and SOPs across Aspen Pharmacare.
    • Maintain awareness of Pharmacovigilance regulatory requirements and developments.
    • Manage outsourced data collection, organisation and preparation with vendors. 
    • Act as Subject Matter Expert (SME) in designated area (e.g. literature, signal management, aggregate reports, labelling etc.) responsible for oversight and coordination of tasks related to the area of expertise.
    • Preparation of annual as well as ad-hoc and scheduled aggregate safety reports.
    • Ensure Good Documentation Practice.
    • Contribute to agreed PV Team quality and compliance targets.
    • Serve in a leadership capacity for complex and strategically important Pharmacovigilance developmental programs.
    • Direct interaction with Regulatory Authorities.

    Financial

    • Identification of project challenges to departmental line management and the financial impact thereof.
    • Project management of contractual and financial aspects of all medical writing projects and the effective utilisation of resources to keep processes cost-effective.

    Medical Writing Accountabilities

    • Work in collaboration with Medical Writers to write clinical documents for submission to regulatory authorities, including but not limited to:
      • clinical overviews and summaries
      • integrated summaries of safety and efficacy
      • Clinical Expert Statements
    • Provide medical editing review of draft and final documents prepared by other team members before internal or external distribution. This includes both copy editing and content review.
    • Ensure document content and style adheres to SAHPRA/FDA/EMA or other appropriate regulatory guidelines and comply with Aspen SOPs and style guidelines.
    • Perform literature searches/reviews as necessary to obtain background information and training for development of documents.

    Safety

    • ICSR (Individual Case Safety Reports)
      • Ensure all cases are processed, medical reviews completed, and cases submitted to Health Authorities as per the timelines specified in the guidelines.
      • Ensure quality checks are performed on weekly, monthly, quarterly and bi-annual reconciliations with internal and external stakeholders.
    • Labelling
      • Updating and reviewing Product Information in line with the Company Core Data Sheets, and other tasks as designated.
    • Aggregate Reporting
      • Preparation of aggregate safety reports including but not limited to PSURs, PBRERs and Addendum Safety Reports.
    • Risk Management System
    • Preparation of Risk Management Systems including but not limited to Risk Management Plans and Risk Communication Plans.
    • Request for Information (RFI) from Competent Regulatory Authority (CRA) and Safety Communication (Dear Healthcare Professional Letter (DHCPL)
    • Manage safety related requests from regulatory agencies and Aspen Affiliates to ensure any requests are answered fully and promptly.
    • Literature Reviews
      • Monitor local literature for designated products and identify safety issues/ ICSRs in a timely manner.
    • Signal detection
    • Coordinate and prepare appropriately for signal management meetings.
    • Signal Management Activities including compilation of Signal Assessment Reports/ Case
    • Series Reviews for potential signals.
    • Creation and update of Safety Data Exchange Agreements (SDEAs).

    Training

    • Oversee training and mentoring of other Pharmacovigilance staff, and prepare training materials 
    • Lead initiatives to develop, implement and conduct appropriate training in all aspects of Pharmacovigilance Safety activities
    • Maintain a high and up-to-date level of product and therapy area knowledge by attending conferences, training courses, reading relevant medical and scientific literature

    QMS

    • Ensure systems and procedures are in place in accordance with the RA QMS and that these are maintained according to the relevant SOPs.
    • Creation and update of SOPs/WIs for all pharmacovigilance activities related to the job role in line with Pharmacovigilance regulations/guidelines (EU, ZA and other territories applicable), within specified/SOP timelines.

    General

    • Adhere to agreed Key Performance Indicators (KPIs)
    • Support the continuous development and improvement of the PV function while upholding Aspen core values
    • Effective management and utilisation of resources to keep processes cost-effective
    • Collating data for ad hoc requests
    • Adherence to Company Health & Safety procedures
    • Participate in training programmes
    • Any other duties as assigned by your Manager

    Requirements

    EDUCATION & EXPERIENCE

    • B. Pharm is a requirement.
    • Documented experience in all aspects of pharmacovigilance is an inherent requirement and not negotiable.
    • 3-5 yrs. pharmaceutical experience with specific focus areas in PV/Drug Safety.
    • Experience working with safety databases.
    • Experience writing large safety reports e.g., DSURs, PADERs, PSURs, PBRERs is preferable.
    • Experience in writing RMPs is desirable.
    • Experience working with MedDRA coding dictionary.

    SKILLS AND ATTRIBUTES

    • Results and performance driven – deliver results that meet or exceed expectations
    • Integrity
    • Work ethic
    • Ability to meet deadlines
    • Sense of urgency – responding to issues and opportunities in a timely manner
    • Intellectual curiosity – willing to suggest and try new ideas
    • Positive and pro-active approach to business tasks
    • Excellent interpersonal and communication skills
    • A solutions provider
    • Manage evolving deadlines effectively with regular feedback and updates
    • Enthusiasm and Drive to take ownership and drive process initiatives
    • Service orientation
    • Customer focused
    • Logical thinking
    • Information seeking
    • Positive ‘can – do’ attitude
    • Be able to work autonomously and have good problem-solving skills
    • Able to cope with evolving deadlines effectively with regular feedback and updates
    • Honest and trustworthy
    • Respectful and highly personable
    • Possess cultural awareness and sensitivity
    • Flexibility & confidentiality are key requirements for this role.

     KNOWLEDGE

    • Strong knowledge of regulatory and medical authorities in South Africa
    • Strong understanding of regulations, ICH guidelines, and GCP
    • Extensive medical writing and expertise in submissions

    go to method of application »

    Detail Sales Representative | NG East | CNS (Pretoria)

    Objective: 

    • To promote and generate sales on key product portfolios to pharmacies on both ethical and generic ranges. In addition to the mentioned objective, the position will also be responsible for building and maintaining strong business relationships with pharmacy decision-makers, in order to drive net sales revenue.

    KEY RESPONSIBILITIES

    • Achieve and exceed set sales targets. (Sales vs Budget)
    • Constant monitoring and driving of sales from customers, scripting from doctors and sales from pharmacies in order to meet set targets.  Sales to be driven at the customer level by effective scientific detailing and use of marketing material.

    Plan - Pre-call planning  on RepWise and daily

    • To be done weekly on Repwise and daily prior to the customer call.  This will ensure that you are prepared for the call. If you have a manager working with you for the day, your pre-call planner must be emailed to the relevant manager, the evening before. Review the available data (Impact Rx, Z-more reports, Shortfall reports, SSD, QlikSense and Swift etc).  

    Achieve Call Rate and CPA objectives

    • See the required number of customers on a daily basis to achieve call rate and at the correct frequency to achieve call plan adherence.
    •  Capture daily calls and activities on Rep Wise.
    • Comms to be done, or as specified by the business. Final Comms to be done after the last call for each day
    • Conduct Doctor or pharmacy activities in line with compliance and regulatory standards.
    • Complete the required number of pharmacy trainings and Doctor/pharmacy activities as required per business and territory requirements

    Requirements

    EDUCATION & EXPERIENCE

    • Matric
    • A valid driver’s license
    • Tertiary qualification or certified sales profession certification would be an advantage.
    • Proficiency in Microsoft applications
    • Minimum 2 or 3 years of proven track record in a sales environment

    Knowledge:

    • Proficiency in Microsoft applications
    • A sound understanding of the pharmaceutical industry
    • Comprehensive understanding of business procedures.

     Skills and Attributes:

    • Effective scheduling and attending of appointments and activities with Healthcare practitioners (Doctors & Pharmacies etc) in order to influence sales and meet sales targets.
    • Implementing strategies to drive sales and growth in the territory
    • Maintain a solid working relationship with customers and colleagues.
    • Territory and customer analysis in order to identify gaps and opportunities to be acted upon.
    • Excellent analytical skills to review available data
    • Clear communication skills both verbal and written.
    • Strong capabilities in logical reasoning in order to address and resolve queries and issues
    • Influencing and negotiation skills.
    • Forward-thinker with the ability to work independently as well as to work as a team player.
    • Good administrate skills in order to ensure that tasks are completed accurately and timeously.
    • Strong work ethic.
    • Establishes and maintains positive relationships (mutual trust and respect) with customers and other stakeholders.
    • Good product knowledge and the ability to utilise detailed material with the correct scientific messaging in order to drive sales

    go to method of application »

    In Process Co-Ordinator (Aspen Office In South Africa)

    Overview

    • Perform in-process testing, sampling and interpret results.

    Responsibilities

    • In-Process Testing and Reporting
    • Conduct in-process testing, compare samples, calculate, interpret, and record testing results.
    • Record defect, out of specification results, reporting these as appropriate
    • Complete required documentation, update and maintain databases and appropriate reports.
    • Ensure that all documentation adheres to signing protocols.
    • Handle, operate, maintain, and calibrate equipment according to SOPs.
    • Comply to GMP/ GLP requirements at all times.

    Reporting and Record Keeping

    • Gather and record information, statistics and evidence required for reporting.
    • Compile standardized reports and consolidate documents.
    • Retrieve supporting documentation and records to facilitate and support query resolution.

    Stakeholder Relations

    • Communicate with internal stakeholders to achieve work objectives, maintain relationships and to assist and convey information.

    Requirements
    Requirements

    Background/experience

    • Grade 12
    • 1 to 3 years’ pharmaceutical manufacturing experience
    • Specific job skills
    • Broad working knowledge of concepts, terminology and specialised reporting requirements

    Competencies

    • Following Procedures
    • Information Gathering
    • Finalizing Outputs
    • Pragmatic Action

    go to method of application »

    Operator - Aspen Office In South Africa

    Description

    Overview

    • Operate equipment in the manufacturing and packing of products.
    • Prepare, clean, and inspect work areas and equipment.
    • Troubleshoot machines and raise maintenance issues.
    • Carry out required training and administrative tasks.

    Operational Support

    • Identify gaps in current policies and procedures.
    • Optimize and facilitate implementation of processes.
    • Operate equipment as per standards and expected efficiency and ensure compliance to GMP and SHE standards.

    Inspections & Verifications

    • Perform pre-production checks such as environmental, scale and equipment pre-checks as per BMR, SOP and product specifications.
    • Verify scale and measuring equipment performance.

    ProductionPreparation

    • Ensure availability of materials and equipment for manufacturing
    • Perform Type-A and Type B changeovers; Clean and prepare the area and equipment before and after processing.
    • Prepare solutions for production activities as per SOP.

    Production Processing

    • Clear and feed the manufacturing line.
    • End of line packing and inspections
    • Perform central lining review to establish optimal production settings.

    Routine Support Tasks

    • Clean area and equipment before and after processing of materials
    • Perform equipment pre-checks and facilitate transfer of equipment.
    • Sort defected product and dispose of according to procedures.
    • Provide information to assist with campaign preparation.
    • Train new Assistants and Operators and transfer of skills
    • Operate manufacturing and packaging lines as per requirements.
    • Resolve minor - and assist with major breakdowns/ maintenance.
    • Perform change overs, settings and minor maintenance as per autonomous maintenance standards.

    Troubleshooting

    • Conduct root cause problem analysis on machines.
    • Raise maintenance issues with management for resolution.
    • Perform adjustments and preventative maintenance on machines.

    Reporting & Record Keeping

    • Complete batch record labels and OEE sheets
    • Perform half-hourly inspections of production area(s)
    • Record manufacturing/ machine down time
    • Attend shift meetings.
    • Perform IPQC or quality inspections per responsible areas.
    • Provide information for reports; consolidate standard documents.
    • Maintain and update records and systems as required.

    Requirements

    Background/experience

    • National Certification (N3) with 0-2 years’ related experience
    • Manufacturing experience

      Specific job skills

    • Basic technical knowledge of pharmaceutical production processes, procedures, systems and equipment
    • Basic understanding of pharmaceutical standards and compliance requirements

      Competencies

    • Finalizing outputs
    • Following procedures
    • Taking action
    • Information Gathering

    go to method of application »

    QA Pharmacist (Port Elizabeth)

    Description

    • Conduct in process compliance to quality procedures, standards, and specifications for value stream operations
    • Review and approve quality related activities for value streams
    • Identify and provide solutions to systematic issues
    • Review Annual Performance Quality Review (APQR)
    • Related administrative tasks

    Requirements

    Planning and Process

    • Provide technical and operational input during drafting of plans and procedures specific to unit.

    Process Compliance

    • Execute day to day QA activities for value streams.
    • Identify systematic technical and process issues by reviewing CAPA requests and trends.
    • Systematic investigation of the root causes of identified problems and risks for corrective action or prevention
    • Develop CAPA plans and change incidents to address process compliance.
    • Implement operational changes to SOPs and processes, in compliance with control processes.
    • Ensure deviations (planned/ unplanned) and concessions are documented, reviewed, and analyzed; and recommend validation activities to be performed.
    • Execute change control process by ensuring changes are documented, reviewed, and approved.

    Annual Performance Quality Review

    • Review APQRs to assess production risks and quality of in process control programs.
    • Review and analyze CAPA plans to assess impact on quality procedures and standards.
    • Retention Sample Management
    • Store and manage retention samples as per guidelines.

    In Process Quality Management

    • Review and approve outcome of in process internal inspections.

    Reporting

    • Monitor the storage of documents on the soft and hard copy filing systems.
    • Maintain and update records and systems as required.
    • Provide information for reports on weekly/monthly basis, as required by superior.
    • Compile standardized reports and consolidate documents.

    Skills Required

    Background/experience

    • Bachelor’s degree (B Pharm) with 4 6 years’ related work experience, or Post Graduate Degree/ Post Graduate Diploma with 2 4 years’ related work experience.
    • Pharmaceutical manufacturing experience 

    Specific job skills

    • Advanced understanding of the pharmaceutical manufacturing and corrective action programs
    • Pharmaceutical standards and compliance requirements
    • Ability to interpret and implement policies, processes, and objectives.

    Competencies

    • Information Gathering
    • Interrogating Information
    • Offering Insights
    • Taking Action

    go to method of application »

    Brand Manager | Consumer (GIT, Cough & Cold) (JHB North)

    MAIN DUTIES:

    • Develop GIT, Cough & Cold portfolio/brand strategy for sustainable business growth and profitability
    • Anticipate future trends in GIT, Cough & Cold usage and the market environment
    • Develop promotional and advertising strategies that grow brand market shares against competitors in all channels (pharmacy, retail, wholesale and informal trade)
    • Analysis of the market, shopper and consumer behaviours and development of insights that are applied to develop robust brand plans
    • Provide creative direction for brand/ portfolios strategies and tactics whilst managing Agency outcomes
    • Implementation, monitoring and measurement of the success of the developed strategies and to ensure that they are flexible to adapt to a dynamic environment
    • Successful implementation and monitoring of the rollout of the above with the required measurements in place for successful outcomes
    • Enthusiastically communicate plans and results with the business leadership and relevant teams within the business at all times
    • Drive, lead and take accountability for the budgeting process, control of A&P expenditure and achievement of financial targets
    • Develop and implement pricing strategies that ensure healthy profit margins and competitive advantage for the GIT, Cough & Cold brands.
    • Continuously communicate with and support the sales teams with high levels of integrity and urgency to help them achieve sales targets
    • Ability to manage the cross-functional networks and channel resources for the portfolio to drive profitable growth with the required and shared accountability to achieve business targets
    • Understand, challenge and implement the regulatory requirements to develop and implement strategies and tactics that drive brand growth
    • Forecasting accuracy and stock management which entails minimizing stock write-off costs and returns
    • Managing wholesalers’ stock holding and backorders.
    • Using insights acquired both internally and externally to accurately assess market potential for new product introductions and/or renovations of existing products
    • Managing and taking the lead/accountability in driving the New Product Launch process together with the relevant stakeholders like NPL, Demand Planning, Regulatory Affairs, Medical and others
    • Lead and utilise both internal and external conferences, and congresses to position GIT, Cough & Cold brands as foremost in the target audience’s minds
    • Sense of urgency in the resolution of customer queries

    Requirements

    QUALIFICATION & EXPERIENCE:

    • Must have a completed Matric/Grade12
    • Relevant Post matric Commercial /Health Science qualification
    • 3+ years FMCG /Marketing industry experience
    • Minimum 3 years brand management within FMCG/Health segment
    • Applicable industry knowledge
    • Sound financial acumen
    • Proficiency in Excel, PowerPoint, Outlook and Word
    • Ability to work on Qlikview models is advantageous

    SKILLS & COMPETENCIES:

    ENTHUSIASM, PASSION AND HIGH ENERGY ARE KEY REQUISITES

    • Commercial acumen
    • Digital marketing skills
    • Analytical skills
    • Project management
    • Networking ability
    • Interpersonal skills
    • Ability to perform under pressure
    • Self-starter and self-motivated
    • Sense of urgency
    • Prioritizing and planning
    • Verbal and written communication skills
    • Aptitude for continuous learning
    • Influential and impactful presentation skills
    • Adaptability and flexibility in a changing environment

    go to method of application »

    Human Capital Business Partner, Eastern Cape (Gqerberha) (Port Elizabeth)

    OBJECTIVE: 

    • The primary purpose of the Human Capital Business Partner is to assist with delivery of a people plan that enables the business to achieve its goals. The job incumbent operates as a member of a business leadership team acting as a business partner providing business-driven insights to support decision-making and determine appropriate business interventions. They also act as coach to the leadership team they support, and a champion, responsible for supporting effective management of people within the business through coaching of business leaders and delivery of a fit for purpose HC service.
    • To facilitate talent acquisition, performance management, development, retention, engagement and separation processes in collaboration with relevant stakeholders and in line with business goals and objectives.

    MAIN DUTIES:

    Employee Relations

    • Advise and coordinate disciplinary inquiries and corrective actions
    • Advise and coordinate the grievance process; oversee the appeals process
    • Ensure consistent application of Disciplinary Code of Conduct
    • Facilitate effective relationships with shop stewards and line management

    Employee Engagement & Retention Management

    • Communicate and educate line managers on HR policies and processes
    • Support, guide and advise line managers on HR related matters
    • Facilitate employee off boarding to ensure minimal disruption to operations
    • Ensure effective implementation of reward and recognition initiatives
    • Facilitate employee engagement initiatives

    Planning and Processes

    • Responsible to manage and oversee audit requests from internal and external service providers in area of responsibility

    Reporting

    • Provide information for reports on weekly/monthly basis
    • Compile standardised reports for area of responsibility
    • Coordinate the gathering of information required for reporting from line management
    • Monitor and control data integrity in all databases in area of responsibility.
    • Retrieve supporting documentation and records to facilitate and support query resolution
    • Maintain Organograms and job profiles on HR systems

    Performance & Talent management

    • Educate and coach line managers on performance tools
    • Ensure KPA’s and KPI’s are in place for all employees
    • Ensure bi-annual performance discussions/ reviews are completed as per Performance Management Plan
    • Manage and facilitate appropriate actions to address poor performance
    • Manage and facilitate appropriate actions to address absenteeism
    • Collaborate with business to identify critical skills and current skills pool; and develop and implement plans to address current and future talent and development needs
    • Execute the succession and retention plans

    Requirements

    EDUCATIONAL REQUIREMENTS & EXPERIENCE

    • Grade 12
    • 3-year Degree in Human Resources or BA/B.Comm degree (Industrial, Psychology or Organizational Psychology)
    • A relevant postgraduate qualification an advantage
    • At least 5 Years’ experience within an HR Generalist role focusing on all facets of the lifecycle of an employee
    • 3 years of significant experience as an HC Business Partner within a complex environment with demonstrated success in meeting exceptionally high standards in a high volume, fast-paced, hands-on environment
    • 2 years of experience advising on Industrial Relations issues
    • Experience in supporting business in an unionized environment to ensure a harmonious workplace environment.
    • Proven track record initiating and implementing projects.
    • Experience using and crafting Excel spreadsheets with the ability to interpret and provide significant insights and recommendations
    • Ability to travel nationally when required
    • Holds a valid driver’s license

    KEY BEHAVIORAL ATTRIBUTES:

    Competencies

    • Needs to be a results-oriented individual with initiative and strong work ethic.
    • Strong verbal and written communications skills, including influencing and ability to support innovation.
    • Highly collaborative style and flexible approach with a willingness and demonstrated ability to work in teams, as both an influential Subject Matter Expert and a supporting team member.
    • Ability to coach, mentor and advise where appropriate to help employees grow and develop in alignment with business and personal goals.
    • Ability to exercise tact and diplomacy to resolve sensitive issues
    • Proven ability to navigate and thrive in a face-paced and dynamic environment.
    • High levels of accuracy and the ability to handle large volumes of administration and not be afraid to "roll up your sleeves"
    • A strong solution focus and be comfortable working in an environment that demands strong deliverables along with the ability to identify problems and drive appropriate solutions

    Knowledge

    • Sound knowledge of acts and regulations (LRA, BCEA, Skill development, Employment Equity act)
    • Understanding of change management principals and models
    • In-depth understanding of the full HR lifecycle
    • Knowledge of performance management and Industrial relations principals
    • Understanding of coaching methodology principals
    • Thorough working knowledge of MS Office, e.g. solid and sound Excel and PowerPoint.
    • Ensure depth of understanding of organisations supported, including key business functions and processes.

    go to method of application »

    Release Pharmacist (Port Elizabeth)

    Description

    • Ensure in-process materials and finished products comply with GMP guidelines, regulation, and in-house SOPs.
    • Determine product release for use into the marketplace.
    • Control of documentation in compliance with regulation and company policies and procedures
    • Related administrative tasks

    Requirements

    Responsibilities

    Planning and Process

    • Implement and coordinate systems and procedures and make decisions within policies and procedures, or as authorized by superiors.

    Product Release

    • Review batch documentation and production conditions to assess compliance to quality procedures, standards, and product specifications.
    • Review and approve quality of new, in process and released batches to assess compliance to quality control programs, product specifications, and GMP guidelines.
    • Approve and release production batches.
    • Execute batch release priorities in line with OTIF and planning schedule.
    • Ensure release requirements are met for finished products.
    • Determine disposition of in process and finished products for clinical and commercial use
    • Ensure changes/ deviations in production or quality control have been approved according to QMS.
    • Initiate tests/ checks/ inspections/ sampling to mitigate any risk associated with planned changes/ deviations.
    • Ensure production and QC documentation are completed in compliance with SOPs.
    • Monitor and audit compliance to regulatory and in house standards with regards to current GMP
    • Report observed deficiencies in process and follow up on corrective action.
    • Investigate systematic quality problems and develop preventative plans, in conjunction with Production.
    • Provide input into GMP related training needs.

    Reporting

    • Complete and consolidate standard documents.
    • File, archive and retrieve documents.
    • Maintain and update records and systems as required.

    Skills Required

    Background/experience

    • Bachelor’s degree with 2 - 4 years’ related work experience, or Post
    • Graduate Degree/ Diploma with 1 - 3 years’ related work experience
    • Pharmaceutical manufacturing experience

    Method of Application

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