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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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Job purpose
- Lead the Centralized Quality Control projects and services, including Stability Management, Investigations, Packaging Testing, Quality Systems and maintenance of laboratory instruments and equipment.
- Manage and guide the unit through team leaders.
- Performance management of direct reports and unit
Responsibilities
Planning and Unit Management
- Interpret, implement and provide technical and operational input into processes, procedures and policies, and monitor operational objectives and plans.
- Make decisions regarding exceptions to policy and procedures.
- Plan, track and collaborate all QC central activities to ensure objectives are met.
- Identify gaps in current policies and procedures.
- Build and maintain relationships with internal/ external stakeholders.
- Provide input into the financial plan and manage budget.
- Ensure availability and optimal allocation of resources within unit.
- Perform HR functions to ensure optimal management of unit.
- Propose changes/improvements to processes, tools and techniques for continual improvement and regulatory compliance.
- Identify training needs of QC Central staff.
Stability Program Management
- Report on storage capacity, calibration, validation and maintenance of stability chambers
- Lead a comprehensive stability study program.
- Oversee data management of local and international stability trials for all Aspen products, and 3rd party products where required.
- Manage the review and approval of stability results and OOSs.
- Manage the Stability Forum and present stability OOS alerts, outcome of technical and analytical investigations, and proposed solutions to product stability failures.
Specification Management
- Manage new specification and methods activities against deadlines to ensure effective and accurate compilation of raw material and finished product specifications.
- Manages routine specification updates based on evaluation and interpretation of current vs latest Pharmacopeial routine requirements.
- Provide expertise and manage communication in order to resolve specification queries from internal and external customers.
- Request special investigations, assess outcome of these and initiate the appropriate actions to minimise risk/ instil preventative measurements.
Technical Transfer management – Analytical
- Manage the development and implementation of method validation, verification and transfer activities in support of technical transfers according to set timelines.
- Ensures the completion of process validation testing in support of technical transfers
- Ensures that methods are in line with regulatory requirements.
- Provides technical support to the QC Laboratories
Laboratory investigation management
- Manage scientific investigations across site laboratories.
- Develop systems and processes for conducting laboratory investigations within GMP environment.
- Provide assistance to the QC laboratories with problematic laboratory investigations.
Equipment Calibration and maintenance
- Manage all laboratory equipment maintenance, calibration, and compliance activities and adherence to specified timelines.
- Ensures that faulty lab equipment is repaired within set timelines and according to policies and procedures.
- Ensures new equipment is qualified and commissioned within set timelines.
- Assist and supports the QC laboratories with equipment trouble shooting.
Packaging Testing
- Oversee the QC testing and release of packaging materials for adherence to standards.
Quality Management Systems
- Equipment Calibration and maintenance
- Manage all laboratory equipment maintenance, calibration, and compliance activities and adherence to specified timelines.
- Ensures that faulty lab equipment is repaired within set timelines and according to policies and procedures.
- Ensures new equipment is qualified and commissioned within set timelines.
- Assist and supports the QC laboratories with equipment trouble shooting.
Governance, Risk & Compliance
- Equipment Calibration and maintenance
- Manage all laboratory equipment maintenance, calibration, and compliance activities and adherence to specified timelines.
- Ensures that faulty lab equipment is repaired within set timelines and according to policies and procedures.
- Ensures new equipment is qualified and commissioned within set timelines.
- Assist and supports the QC laboratories with equipment trouble shooting.
Requirements
Skills Required
Background/experience
- Minimum of Bachelors Degree in Chemistry or Pharmacy with 10 years’ related work experience
- Supervisory experience
- Analytical laboratory and specifications management experience
Specific job skills
- Expert knowledge and advanced understanding of packaging testing, and raw material and finished product analysis.
- Advanced understanding of pharmaceutical and pharmacopeial testing, ICH stability guidelines and regulatory body guidelines for specifications and methods of analyses
- Advanced understanding of pharmaceutical manufacturing and corrective action programs, standards and compliance requirements
- Ability to interpret and implement policies, processes, and objectives.
Competencies
- Offering Insights
- Creating Opportunities for Collaboration
- Customer Awareness
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Job purpose
- Approve local suppliers.
- Monitor and support supplier-related activities and technical agreements.
- Coordinate and execute internal and supplier audit programs.
- Provide expert support to company and supplier sites to ensure successful regulatory inspections.
- Continuous compliance of corporate and supplier audit programs
- Related administrative tasks
Responsibilities
Vendor Management
- Review and approve new suppliers.
- Interpret, implement, and maintain supplier technical agreements.
- Build and maintain supplier relationships to ensure timely audits, effective communication, and to resolve deficiencies/ concerns.
- Implement principles, processes, and tools to manage suppliers.
- Monitor compliance of supplier activities and contracts to GMP standards and technical agreements
- Monitor vendor performance to established performance metrics and communicate performance issues.
Vendor Audit Management
- Coordinate, schedule and conduct supplier and service provider audits to assess compliance.
- Issue audit reports and follow up on responses to audit findings, including CAPA plans, close out supplier audits.
- Perform due diligence visits/audits of potential new suppliers.
- Provide recommendations on suitability and compliance of suppliers.
- Propose follow-up remediation or CAPAs relevant to new suppliers.
Internal Audit Management
- Coordinate, schedule, and conduct quality audits of company sites to assess compliance to GMP, MCC and international standards.
- Conduct statutory internal audits as required by local authorities.
- Prepare audit reports and review audit findings with unit managers.
- Assist in audit investigations and provide input into CAPA plans.
- Perform follow-up on unit actions plans and close out audits.
- Prepare, update and review proposed changes to SOPs.
Governance, Risk & Compliance
- Provide input and evaluate changes to audit system to improve quality of audit.
- Provide technical and regulatory guidance to internal and external stakeholders to ensure overall quality and compliance.
- Ensure compliance of company and supplier audit programs
Reporting
- Ensure timely input of data into the audit system
Requirements
Skills Required
Background/experience
- Bachelor’s degree in science or science-related field, with 4-6 years’ related experience or Post Graduate Degree or Diploma in Science or Science-related field with 1-3 years’ related experience
- Industry recognised audit qualification preferred.
- Experience in GMP regulated industry in a QA and auditing role.
Specific job skills
- Excellent knowledge of good manufacturing regulations in pharmaceutical industry
- Pharmaceutical standards and compliance requirements
- Ability to interpret and implement policies, processes, and objectives.
- Ability to operate and audit within all global cultures.
- Project management.
Competencies
- Information Gathering
- Interrogating Information
- Offering Insights
- Taking Action
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Description
Fine Chemicals Corporation requires the services of a highly competent individual to fill the position of Production Shift Supervisor. To qualify for this position candidates must fulfill the following requirements.
Requirements
JOB REQUIREMENTS:
- Grade 12 with Mathematics & Physical Science as subjects.
- A desirable qualification encompasses a National Diploma and/or BTech in Chemistry or Chemical Engineering, or a comparable qualification compliant with the National Qualifications Framework (NQF) would be advantageous.
- Must have 5 years of relevant experience in a chemical/pharmaceutical/manufacturing environment.
- Experience in a supervisory or leadership position would be advantageous.
- Good working knowledge of cGMP (current Good Manufacturing Practice) and GDP (Good Documentation Practice) pertaining to the manufacture of Active Pharmaceutical Ingredients (APIs).
- Be trained as a firefighter take responsibility for fire training and be an integral part of the emergency response team.
BASIC JOB FUNCTIONS (Brief Summary):
- Manage the operational activities of Active Pharmaceutical Ingredients (API’s) manufacturing according to the production plan and in accordance with the applicable quality management system requirements.
- Ensure that the product produced, in the production facility, conforms to the relevant quality and standards as they relate to customer demands and criteria, GMP, training, and OHSE matters.
- Optimise systems, processes, and procedures and ensure that plant resources are utilized effectively and efficiently.
- Effectively and efficiently manage staff and handling of conflict.
- Maintain GMP in the area with particular attention to documentation control, ERP, and general housekeeping.
- Establish and maintain appropriate systems for operational management and measurement.
- Comply with GMP requirements as outlined by Company SOP’s and written instructions in all tasks and activities.
- Adhere to all Company OHSE rules and regulations.
- Management of the company’s fire team.
- Responsible for fire team training.
- Responsible for management of the site after hours.
- Must be able to work shifts.
PERSONAL ATTRIBUTES (Brief Summary):
- Must be organised, hands-on, disciplined, and honest.
- Must show good leadership skills and have an eye for detail and accuracy.
- Must be able to work and perform under pressure in a highly regulated environment.
- Good interpersonal skills.
- Good communication skills (written and verbal).
- Attention to detail.
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Job purpose
- Review and approve quality related activities for value streams.
- Identify and provide solutions to systematic issues – risk assessments and reviews.
- Monitor compliance to GMP and statutory requirements and internal warehouse audits.
- Monitor adherence to guidelines, procedures and document controls.
- Deliver expected value stream targets as per business requirements.
- Warehouse GMP compliance
- Team and process development
Responsibilities:
Staff development
- Facilitating training sessions as required related to improvements and CAPA’s.
- Train Warehouse Pharmacist and PMAs on SOPs in transition periods - improvements of systems
- And stand-in when needed within the warehouses.
Planning and Process
- Provide technical and operational input during drafting of plans and procedures specific to Unit
Process Compliance
- Execute day-to-day quality activities for value streams related to department
- Identify systematic technical and process issues by reviewing CAPA requests and trends
- Develop CAPA plans and change incidents to address process compliance within the department
- Implement operational changes to SOPs and processes, in compliance with control processes
- Ensure deviations(planned/unplanned) and concessions are documented, reviewed, and analysed and recommend validation activities to be performed
- Execute change control process by ensuring changes are documented, reviewed and approved.
- Ensure process compliance up to date in all departments and drive close out of these.
In-process Quality Management
- Review and approve outcome of in-process internal inspections.
Product release management
- Deviation management and adherence to daily, weekly targets.
- Review and approve deviations, assist in investigations as required and implement corrective actions.
- Maintain and update records and systems as required.
- Ensure deviation owner allocation and re-allocation in accordance to prioritize.
- Ensure CAPA actions are implemented (deviations, CAPAs, Change Controls)
Process and System improvements
- Manage, review, and approve change control programs and deviations/concessions comply to standards and specifications.
- Optimize processes and identify gaps in procedures.
- Drive CAPA investigations in areas of focus.
- Initiate formal and informal RA (Risk Assessments) for quality related topics for new processes.
Stakeholder management
- Key interface between warehouse and support departments with main interface being with QA department.
- Customer interface as needed to share information, feedback on open items, retrieve guidance and facilitate priorities.
Customer Relations
- Important communication required with external customers regarding quality expectations of a product.
- Implementing quality protocols which aligns with the customer.
GMP Compliance
- Facilitate and support audit management in all warehouses.
- Enforce and control area compliance (personnel, documentation, process, product)
- Ensure warehouse process adherence to standards and specifications.
- Enable teams and process to achieve documentation and deviation right first-time targets.
- Serve as Deputy RP at Aspen distribution centre.
Requirements
Background/Experience:
- Bachelor’s degree (B.Pharm) with 3-5 years related warehouse or logistics work experience.
- Pharmaceutical manufacturing or dispensing 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
- Leadership
- Managing complex task and integration of multiple variables
- Interrogating information
- Offering insights
- Taking action
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Description
Fine Chemicals requires the services of a Process Operator Grade 04. To qualify for this position suitable candidates must meet the following requirements.
Requirements
JOB REQUIREMENTS:
- Matric/ Grade 12/N3 with mathematics and physical science/biology and/or equivalent National Qualification Framework levels as per SAQA.
- Must have operated as a Grade 3 for at least 3 months.
- Must have an aptitude for process understanding and work with your hands.
- Must have the ability to be trained and of good health.
BRIEF JOB FUNCTIONS (Brief Summary):
- To manufacture Active Pharmaceutical Ingredients (API's) by following prescribed procedures.
- Monitor the execution of production plans and take corrective measures where necessary. Ensure that contingency plans are developed and implemented.
- Follow instructions as guided by either the Grade 6/7 or the Supervisor.
- Ensure that the work area is maintained in a current Good Manufacturing Practices (cGMP) compliant state.
- To be conversant with all relevant batch processes manufactured in the production block.
- Understand and accurately transcribe data onto BPR and related/supporting documentation.
- Take full control of batch processes on a day-to-day basis as directed /instructed by the Grade 6/7.
- To be proactive in reporting any equipment deficiencies or process-related problems to the Grade 6/7 or the plant Supervisor.
- Comply with GMP requirements as outlined by Company SOP’s and written instructions in all tasks and activities.
- Review Batch Production Records (BPRs) at the end of the shift and ensure that good documentation practices are continuously exercised.
- Adhere to all Company OHSE rules and regulations.
PERSONAL ATTRIBUTES (Brief Summary):
- Good communication skills.
- Must be able to work and perform under pressure in a highly regulated environment.
- Must be of sober habits and be willing to work shifts and overtime as operationally required.
Method of Application
Use the link(s) below to apply on company website.
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