Current Opportunities at Aspen Pharma Group

Description

• Review and approve batch documentation in line with SOP and quality standards.
• Perform lab quality review in line with SOP.
• Provide services according to Production plan.
• Related administrative tasks.

Planning and Operational Support

• Oversees work and/ or serve as a lead technical expert.
• Optimize and facilitate implementation of current processes.
• Identify gaps in current policies and procedures.
• Propose changes or improvements to processes, tools and techniques.
• Provide information for reports, as required by superior.
• Provide analytical support in the absence of the TL.
• Provide support during regulatory audits.

Lab Quality Review

• Perform LQRs according to Production plan.
• Review and approve lab records to ensure pharmaceutical analysis has been carried out as per MOA, direct queries to laboratory.
• Electronic approval of analytical results on relevant software. e.g., Empower
• Evaluate and interpret chromatography data to ensure accuracy of results.
• Review and approve batch documentation compliance with SOPs and quality standards.
• Correct errors in batch documentation, in line with GMP standards, SOPs, and product specifications.
• Record all OOS investigations and conclusions, and report to management.
• Provide advice to analysts during laboratory investigations.
• Provide input into SOPs.
• Ensure that products are produced, tested and stored according to the required SOP’s and documentation.
• Ensure adherence by Analyst/ Tester before release.

    Reporting and Record-Keeping

• Document and store data according to SOPs and regulation.
• Consolidate information for reports on weekly/ monthly basis.
• Analyse consolidated data and provided recommendations.
• Compile detailed and standardized reports and consolidated documents.
• Initiate deviations once picked up during reviewing.

Requirements
Background/experience

• Microbiology degree /similar with 6+years’ experience
• Laboratory experience

Specific job skills

• Understanding of pharmaceutical manufacturing and corrective
• action programs
• Pharmaceutical standards and compliance requirements.
• Ability to interpret and implement policies, processes and objectives.
• Strong technical knowledge and be competent in the use of all laboratory equipment, software and techniques.

Competencies

• Interrogating
• Information
• Following Procedures
• Maintaining Accuracy
• Customer Awareness

go to method of application »

Description

• Perform QC and stability tests on raw materials, in-process and finished products, components and water to ensure quality and compliance. Review compliance of products to GMP, quality standards, and product specifications. Provide services according to Production plan.

 Responsibilities

Planning and Operational Support

• Optimize and facilitate implementation of current processes.
• Propose changes or improvements to processes, tools and techniques.

Test Preparation

• Prepare and analyze samples according to SOPs.
• Prepare and operate laboratory equipment according to SOPs.
• Prepare reagents and solutions for testing.
• Maintain good housekeeping.

Testing

• Perform HPLC/GC analysis using MOA.
• Perform routine analysis on in-process and final products, raw materials and components.
• Perform routine stability tests such as related substances, assay and dissolution to assess quality of product.
• Perform daily and weekly water testing according to SOP.
• Support testing for OOS investigations to establish any systematic issues in process or testing.
• Handle problems efficiently according to quality policy
• Report feedback on services or outputs regularly to customers
• Check HPLC/GC runs regularly during the shift.
• Provide internal customers with accurate HPLC/GC results.
• Propose, develop and update methods for improving customer service.
• Check, document and report operational output against actuals.
• Communicate deviations for production and process improvements.
• Utilize technology as per qualification requirements.

Reporting and Record-Keeping

• Document and store data according to SOPs and regulation
• Consolidate information for reports on weekly/ monthly basis.
• Analyse consolidated data and provided recommendations.
• Record, interpret and report testing results to management, including OOS results.

Requirements

Background/experience

• National Diploma in Analytical Chemistry with 2+ years’ experience
• Laboratory experience

 Specific job skills

• Advanced understanding of pharmaceutical testing methods
• Understanding of pharmaceutical manufacturing and corrective
• action programs.
• Knowledge of Millennium Software (HPLC) and GC Software
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives.

 Competencies

• Interrogating Information
• Meeting Deadlines
• Following Procedures
• Maintaining Accuracy
• Customer Awareness

go to method of application »

OBJECTIVE:

• Leads, Oversee and Co-ordinate Procurement staff to achieve goals that contributes to the growth of the organisation relating to the Procurement activities by assisting with procuring of goods and services and ensuring that all business requirements are attended to timeously.

KEY RESPONSIBILITIES

Analyse: Purchase requisitions, Purchase Orders report, Open Purchase orders and Receipting

• Extract, review and direct workflow to the Procurement staff. Analyse purchase requisitions that are not converted to Purchase orders and or RFQ’s. Analyse Purchase orders that are not yet approved and receipted 

Reporting

• Preparation of weekly reports (Purchase Requisitions, Purchase Orders in approval and Open Purchase Orders). Month end Procurement reports. 1st Review on Master Data Audit Report.

Customer Service

• Attending and resolving all queries from business and Accounts Payable timeously

Coaching

• Attract, develop, and retain high quality team members.
• Lead the team as a role model who demonstrates Aspen’s values, inspires, motivates, and coaches team members to maximise the quality of their output
• Drive ownership, accountability innovation and efficient processes.
• Learning solutions are identified, proposed and implemented according to on-going personal and team development plans.

Projects (Planning & Execution)

• Weekly, monthly refresher training sessions with Users. Involvement with Master Data process (changes and/or additions). Process optimisation or Innovation for departments including interaction with other departments regarding cross-functional impacts or risk of proposed process changes and prepare for projects (test changes, training materials, SOP’s and Business communications)

Requirements

SKILLS AND ATTRIBUTES:

• Initiative
• Multi-tasking
• Systems thinking
• Resource efficiency
• Problem-solving and good judgment
• Responsibility and accountability
• Resilience
• Focus
• Informal communications skills
• Active listening skills
• Writing skills
• Presentation skills
• Meeting facilitation
• Empathy
• Technical / professional knowledge
• Leadership
• Coaching and counseling
• Curiosity / learning agility
• Ethical conduct
• Employee selection & on-boarding
• Flexibility and tolerance for ambiguity
• Transition management
• Capacity for and resistance to Stress
• Perseverance and tenacity

KNOWLEDGE:

• Computer skills on SAP and Excel
• A solid understanding of business requirements
• A working knowledge of Procurement and Pharmaceutical
• A solid understanding of Procurement Policies, SOP’s and BBB-EE

EDUCATION & EXPERIENCE

• Matric /Grade 12 certificate
• Commercial Diploma or Degree
• 3 Years minimum experience in Procurement operations 

go to method of application »

Overview

• Monitor manufacturing compliance to GMP and statutory requirements
• Monitor adherence to guidelines, procedures and document controls
• Deliver expected productivity targets as per business requirements
• Related administrative tasks
• Serve as back up to Team Leader on shift

Requirements

Responsibilities

Planning and Procedures

• Plan and prioritise daily, weekly and monthly activities
• Determine, request and use resources/ assets optimally

Inspections and Verifications

• Verify schedule 5 products
• Verify certified clean status of rooms and equipment
• Verify, review and approve verification of measuring equipment performance, calibrations and sampling, and dispensing of materials

Line & Production processing

• Perform, review and approve line sign-on’s, closures and clearance authorisations
• Perform, review and approve batch reconciliations to product specifications and quality
• Ensure production process adherence to standards and specifications

Process and system improvements

• Manage, review and approve change control programs and deviations/ concessions comply to standards and specifications
• Manage and resolve customer complaints
• Optimise processes and identify gaps in policies/ procedures
• Drive CAPA investigations in area of focus

Compliance & Auditing

• Perform and review shift GMP checks, environmental checks, and agent expiry dates, and ensure continued compliance
• Verify good document practice as per SOP and regulation
• Verify the identity of bulk product and printed packaging materials, and conduct intermix checks to assess uniformity
• Verify IPCs are in line with product quality and specifications
• Review and approve preliminary batch records
• Audit logbooks and systems

Troubleshooting

• Investigate deviations and concessions, and assess risk
• Raise deviations and implement corrective action
• Raise maintenance notifications as and when required

Training and technical expertise

• Train new Pharmacists and PMAs on SOPs in transition period
• Identify refresher or awareness training needs

Administration & Record keeping

• Complete batch records and labels
• Complete deviation forms as required
• Query documents and sign off declarations
• Perform and verify calculations in BMR
• Maintain and update records and systems as required
• Retrieve supporting documentation and records to facilitate and support query resolution

Skills Required

Background/experience

• Bachelor’s degree in Pharmacy
• 1-3 years’ related work experience
• Pharmaceutical manufacturing experience
• Registration with Pharmacy Council

Specific job skills

• Comprehensive knowledge of pharmaceutical manufacturing, standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives

Competencies

• Information gathering
• Interrogation Information
• Meeting deadlines
• Finalising output
• Taking action

Accountability & Decision Rights

• Work on assignments of moderate size, scope, diversity and/ or complexity
• Seek guidance when needed

Decisions relating to:

• Own work methods, occasionally in ambiguous situations, guided by precedent, previous experience and known professional guidelines/ compliance requirements
• Interpretation of policies, standards, requirements and approaches
• Setting of work priorities

go to method of application »

Description

• Ensure the quality of Packaging components complies with specification and approved artwork.
• Ensure compliance with site, 3rd party customer / local and international regulatory requirements and project timelines.

Requirements

Responsibilities

Planning and Section Management

• Provide input into and independently implement and coordinate systems and procedures.
• Provide section staff with day-to-day direction and tasks.
• Determine, allocate and request required assets and resources for the fulfilment of work objectives; and monitor its use.
• Develop new and facilitate implementation of current processes.
• Propose changes or improvements to management on processes, tools, techniques, and products.
• Provide input into and manage budgets and resource requirements.
• Train and assist junior staff.

Packaging Testing

• Manage the QC release process for printed components against approved artwork files
• Manage QC release process of packaging components against approved specifications.
• Manage packaging specifications evaluation and implementation.
• Ensure compliance with MCC and International Regulatory Authority requirements.
• Ensure the on-time release of all packaging components to meet production schedules.
• Coordinate and conduct package testing according to SOPs.
• Review labelling/ artwork and identify mislabelling / breaches; manage discrepancies.
• Ensure packaging is staged for sampling and testing, in line with requirements.
• Ensure labelling is complete as per SOP.

Reporting and Record-Keeping

• Consolidate information for reports on weekly / monthly basis
• Analyse consolidated data and provide recommendations.
• Compile detailed reports and consolidated documents.
• Monitor and control access to and set-up of electronic databases.

Governance, Risk & Compliance

• Provide input for improvement of risk-based compliance systems
• Monitor implementation and correct own and/or team compliance with legislation, policies, and procedure.

Skills Required

Background/experience

• National Diploma in Packaging Technology or related degree with 5 years’ related experience
• Supervisory experience

Specific job skills

• Advanced knowledge of packaging equipment, artwork origination, and printing processes, and package testing
• Scientific report writing skills.
• Understanding of pharmaceutical manufacturing and corrective action programs
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes, and objectives.

Competencies

• Managing Performance
• Planning and Organising
• Meeting Deadlines
• Customer Awareness

go to method of application »

Overview

• Perform microbiological tests on raw materials, water, cleaning and environmental samples, in-process and final products to ensure quality and compliance
• Review compliance of documentation according to pharmaceutical standards

Responsibilities

Planning and Operational Support

• Optimise and facilitate implementation of current processes
• Identify gaps in current policies and procedures
• Propose changes or improvements to processes, tools and techniques

Microbiological Testing

• Perform microbiological tests on raw materials, in-process and final products to ensure quality and compliance with GMP standards
• Test water according to SOPs and testing schedule
• Notify Production of source of any contamination timeously
• Develop and implement plans to control level and source of contamination

Environmental Management

• Perform sampling and testing of external environment, according to SOPs and sampling plan/ schedule

Quality Control

• Report OOS results and deviations immediately
• Manage frequency of testing and sampling to maintain a quality process
• Maintain good housekeeping
• Manage and coordinate the use, maintenance and calibration of testing equipment according to SOPs
• Ensure continuous compliance of laboratory with GMP standards

Reporting and Record-Keeping

• Document and store data according to SOPs and regulation
• Consolidate information for reports on weekly/ monthly basis
• Analyse consolidated data and provide recommendations
• Compile detailed and standardised reports and consolidated documents

Requirements

Background/experience

• National Diploma in Microbiology with 6+ years experience
• Microbiological laboratory experience

Specific job skills

• Advanced knowledge of microbiological testing methods
• Understanding of pharmaceutical manufacturing and corrective action programs
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives

Competencies

• Interrogating Information
• Following Procedures
• Maintaining Accuracy
• Customer Awareness