SUMMARY:
BPharm Degree or Dip Pharm
POSITION INFO:
Our Client requires a QA Pharmacist to contribute to its mission of establishing local biological and vaccine manufacturing capability at its Cape Town based site. Being the only one of its kind in South Africa, our client strives to respond to the vaccine needs of the developing countries, specifically South Africa and Sub-Saharan Africa. This is a particularly exciting time for the company as it continues to grow, strengthen, and build on its success and further develop its capabilities, products, services and market diversification.
The successful incumbent will report to Senior QA Pharmacist
Job Purpose
- Responsible for all QA Pharmacist related activities including but not limited to:
- Coordinate specified Pharmaceutical Quality Systems Documents, Plans and Reports.
- Assist in coordination of customer and regulatory audits and participate in the audits.
- Perform QA functions at the appropriate standards (SA GMP, PIC/s and WHO) to ensure that products are of the quality for their intended use.
- Ensure compliance with the Medicines and Related Substances Act 101 of 1965, Pharmacy Act 53 of 1974 and the organization’s policies, procedures, and other applicable laws.
- Ensure review of batch records and final release of product to the market for sale. Ensure compliance in accordance with the Medicines and Related Substances Act 101 of 1965 and the Pharmacy Act 53 of 1974, and the organization’s policies, procedures, and other applicable laws.
- Continuously build and support a sound quality assurance culture aligned to cGMP within the company.
Key Duties & Responsibilities
Core Technical Delivery
Release Functions
- Review all manufacturing batch records and packing batch records
- Approval and final release of manufacturing products to the market and/or third party as applicable.
- Evaluate and authorise reprocessing of products or materials.
- Ensure that products are released in accordance with appropriate marketing authorisation following full batch and testing record review.
- Assist QA Release and Outsource manager and participate in investigations in the event of medicine recalls and compile relevant reports.
- Adhere to Quality Standards in order to comply with SAHPRA and PIC/S guidelines with regards to for e.g.:
- Product sampling for re-testing.
- Batch documentation auditing and control.
- Finished product release.
- Quality of products out in the market.
- Storage and control of retention samples.
- Review monitoring of temperate on incoming shipments (relating to deviations).
- Monitoring of stock control system to control authorised product release, quarantine, and release of stock.
- Respond and manage quality reviews to adverse drug reactions post immunization and participate in investigations with the pharmacovigilance officer
- Provide a quality reports on adverse drug reactions post immunization to Pharmacovigilance Officer
Compliance
- Deviation and Corrective Action Processes by promoting a culture of immediate reporting and ensuring that Deviations are tracked on all affected batch and testing records.
- Assist in ensuring that all SOP’s within own section are reviewed, authorised, and are regularly monitored, adapted and improved to ensure compliance to GMP standards and the product license.
- Apply a continuous improvement process.
- Assist with drafting review and update of policies, guidance documents, manuals, master and summary files.
- Ensure compilation of Annual Product Reviews for all products processed on site during the preceding year.
- Ensure Annual Reports are completed where required.
- Participate in Regulatory and Customer Audits.
- Consolidate responses, track completion, and close out of findings for own section.
- Assist with the compilation of quality & operations council reports for own section
- Review plans and documents against cGMP standards, and improvement plans as requested and participate in auditing when required.
Outsource
- Actively participate in the development contract manufacturing/outsource sub section within the company.
- Participate in writing and updating of SOPs where required.
- Ensure that all current master documents which includes but not limited to specifications, batch records are available and maintained as per SOP.
- Design, plan, implement maintain, improving and actively participating
- Compile and write Product Quality Reviews.
Quality Management
- Building own cGMP knowledge and compliance
- Participate in achieving quality objectives.
- Participate in building a sustainable Quality Culture on site and proactive mitigate risks that may negatively impact quality or escalate these appropriately
- Ensuring audit readiness within own role through closing out audit findings timeously
- Ensure Deviations, Change Controls, CAPAs are handled effectively
- Advocate continuous improvement
Technical Competencies required to perform this aspect of the role:
- Good understanding and working knowledge of Quality Systems.
- Knowledge of pharmaceutical industry standards and guidelines in GMP and Quality
- Documentation Management
- Technical Report Writing
- Standard Operating Procedures
- cGMP knowledge
- Total Quality Management & Quality Management Systems
- Data development, trending & reporting
Generic Competencies required to perform this aspect of the role:
- Planning, Organising, Execution
- Creative Problem Solving & Innovation Skills
- Sustainable Stakeholder Management
- Commercial Awareness
- Action & Results Oriented
- Assertive & Resilient
- Adaptable in Responding to change
- Negotiation and influencing skills
- Proactive in mitigating risk
- Clear, timely and effective communication skills both verbally and in writing
- Analytical Ability
Experience & industry accreditation/ knowledge
Required:
- Knowledge in quality assurance and/or cGMP/ Pharmaceutical manufacturing environment.
Preferred:
- Previous experience within quality management, particularly with quality systems.
- Knowledge of Pharmaceutical related legislation.
- Experience in having faced successfully local and/ or international quality audits.
- Experience in aseptic (sterile) manufacturing.
- Technical report / process writing skills
- Microsoft Office
Qualifications
Required
- BPharm Degree or Dip Pharm.
Recognition is given to Prior Learning and practical experience.
Other Requirements
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