For more than 130 years, Boehringer Ingelheim has been committed to the research, development, and manufacturing of new medications with high therapeutic value for people and animals. As a family-owned pharmaceutical company, Boehringer Ingelheim is able to take a long-term view and invest heavily in research and development. We are proud of addressing some ...
Establish, maintain and improve the Quality Management System in South Africa and Lead the Quality Management Reviews (QMR) in South Africa
Responsible Pharmacist performing Batch Market Release as per the local Health Authorities Regulations. And decide on the final disposition of returned, rejected, recalled or falsified products
Coordinate and promptly perform any recall operations for medicinal products and owner of the LAC (Local Advisory Committee) ensuring proper escalation of major and critical Product/Quality Defects
Ensure that relevant customer complaints are handled effectively on timely manner
Handle deviations, investigations and CAPAs. Ensure adequate CAPA plans are tracked for completion.
Ensure that initial and continuous training programs are implemented and maintained.
Manage audits by Corporate or inspections by local Authorities in respect to GMP/GDP.
Ensure that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place
Manage external GxP service providers in all quality relevant aspects during the life cycle of a contract. This might include the following GxP service providers:
Re-packagers – secondary packaging distributors
freight forwarders
warehouses
graphic offices
contract laboratories
Co-promotion / Co-Marketing partners
Out-licensing partners
Outsourced services with GMP/GDP relevance
Requirements
Must be a Pharmacist, licensed by the Local Health Authorities and registered as the Responsible Pharmacist.
Degree in Pharmacy
Solid experience in quality management with minimum 4 years of leadership experience
Strong knowledge of international regulations/guidelines concerning GDP/GMP and Quality Assurance
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