- Approval of the technical specifications and validation protocol or report to enable production readiness.
- Liaison with site QA to ensure that any specific documentation requirements are known and planned for.
- QA approver on Change Control linked to initiatives (Veeva GTRAQ).
- Responsible for ensuring that QATA with manufacturing sites and DC’s are in place before initiative hand-over.
- PHC category site support for investigations, deviations or CAPA’s etc.
- Provide input to the design of consumer tests to ensure that GMP requirements are maintained.
- Provide QA support for qualification of new raw and pack material suppliers for PHC Managerial responsibilities.
- Degree in health-related science, life science, pharmacy or medical degree with good professional QA experience.
- Comprehensive demonstrated working knowledge of principles and concepts of Quality Assurance and Contract Manufacturing Organisations.
- Understanding of basic manufacturing processes in terms of making and packing of multiple product forms using GMP standards.
- In depth knowledge of manufacturing medicinal products and food supplements.
- Understanding of the Innovation work processes, SIMPL process, quality systems, stability, validation and GMPs.
- Able operate with great autonomy in a dynamic environment with the ability to think strategically, lead and influence people.