QA Release Pharmacist - Midrand at MSD

Job Description

The Quality Assurance Release Pharmacist will have responsibility to ensure all products are released for sale according to Good Manufacturing Practice (GMP) requirements and within set timelines. 

The position ensures quality standards, processes and specifications are in line with registered information and global GMP requirements.

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.  Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

Primary Responsibilities:

• Management and oversight of the release of all finished, packaged product to the market.
• Management and oversight of the release of bulk product for primary and secondary product packaging.
• Management and oversight of the release of fully packaged & imported products.
• Implementation of and adherence to our Company's global and Health Authority requirements for batch disposition.
• Participation in deviation classifications and investigations, Quality Risk Management and Change Control Systems.
• Participation in Health Authority and Global quality audits.
• Participate in and lead [as required] meetings, problem solving sessions and strategy development plans with company representatives for which our Company operates as a Contract Manufacturing Organization.
• Management of retention samples.
• Ensuring that bulk and product are released on time as per the Company's scheduled release dates.
• Collaborating with the Quality Control lab, warehouse, production teams to ensure release of bulk and product on time as per the Company's set release dates.
• In-market quality responsibilities for products at our third-party logistics (3PL) distributors.

Education:

• Degree in Pharmacy

Experience:

• Minimum of 1-3 years managing product releases end to end in the pharmaceutical industry.
• Experience in the Quality Assurance pillar.
• Experience in Good Manufacturing Practices
• A good understanding of SAHPRA GMP requirements.
• A good understanding of Market Authorization Holder requirements
• Experience in SAP