Website The Biovac Institute
The Biovac Institute requires a Quality Assurance Pharmacist to contribute to its mission of establishing and maintaining effective value creation for its biological and vaccine partners and stakeholders within its current and future commercial footprint. Being the only one of its kind in South Africa, Biovac strives to respond to the sterile injectable needs, particularly related to vaccines and other biologicals, South Africa, Sub Saharan Africa and other developing countries. 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 the Section Head: Quality Assurance Systems
Summary of role
- 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.
- Pharmaceutical support to the API section
- Pharmaceutical alignment of technology transfer documentation to ensure adherence to cGMP, Biovac’s policies and processes and relevant legislation.
- Develops and updates SOPs and Work Instructions on a continuous basis
- Work with API production team to develop batch records for the area
- Review, Approval and final release of manufacturing products
- Assist QA Manager and participate in investigations in the event of medicine recalls and compile relevant reports.
- Adhere to Quality Standards to comply with MCC and PIC/S guidelines with regards to for e.g.: Batch documentation auditing and control.
- Finished product release.
- 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.
- 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.
- Coordinate Change Control initiatives and manage changes, including required authorisations. Establish and apply continuous improvement processes.
- Building own cGMP knowledge and compliance
- Participate in achieving the company’s quality objectives.
- Participate in building a sustainable quality culture on site and proactive mitigate risks that may negatively impact quality or escalate these appropriately.
KNOWLEDGE & CAPABILITY REQUIREMENTS TO SUCCEED IN THIS ROLE:
- Knowledge in quality assurance and/or cGMP/ Pharmaceutical manufacturing environment.
- 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
- Experience in Phase 1 clinical trial manufacturing.
- Experience in manufacturing of clinical trial material, preferably API.
- Experience in successful licence application for clinical trial manufacturing.
- Experience in pharmaceutical technology transfer projects and applicable documentation required.
- Sound technical ability and hands on approach.
- Sound ability to write and review documentation for manufacturing implementation.
- BPharm Degree or Dip Pharm.
- Recognition is given to Prior Learning and practical experience.
- Potential shift work, reliable transport, ability to conduct road and air travel
- 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
- Planning, Organising, Execution
- Creative Problem Solving & Innovation Skills
- Sustainable Stakeholder Management
- 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
- Pharmaceutical documentation writing and review.
All positions will be filled in accordance with our Employment Equity policy as The Biovac Institute is committed to the pursuit of excellence, diversity and redress. Interested persons to kindly submit their CV’s to firstname.lastname@example.org by 30 June 2018.