Site Quality Lead - Midrand at MSD

Position Overview - Basic Functions & Responsibility

The role reports to Associate Vice President – Quality and is part of Global pharmaceutical operations Packaging Quality leadership team. Implementation of and management of the quality system at the site in accordance with divisional and local requirements. Champion GMP activities at the site by fostering GMP awareness and conformance to the plant's GMP commitment. The role also oversees the quality and release activities for our company's directly imported products into SA and related GDP activities. 

• Management of Quality operations department by ensuring adequate staffing and training to undertake the responsibilities for Quality activities and ensuring adequate performance management.
• Ensure a Quality management system is in place in accordance with our company and local regulatory requirements.
• Ensure all materials and products are tested and released or rejected in accordance with Specifications including materials tested by external laboratories.
• Final approval for reports such as; Internal and external customer complaints; Manufacturing deviations; OOS or atypical analytical test results
• Play a key role in developing corrective actions and preventive actions and ensure they have been effectively implemented.
• In cases of significant deviations, initiate and conduct fact-finding activities and report to divisional recall committee where applicable, through responsible QA Business Head.
• Monitor site's abilities to recognize and correct system problems by evaluating the number and types of deviations generated.
• Ensure hold time stability program for intermediate products and stability program for finished products is in
• place as advised by divisional stability hub.
• Establish and approve local Standard Operating Procedures that impact product quality. Assure conformance to divisional Policies, Procedures and Guidelines.
• Ensure compliance with current Good Manufacturing Practices, Good Distribution Practices and quality policies in all site departments involved in packaging activities or those that support packaging and distribution activities.
• Review and approve where necessary validation and applicable qualification activities related to: Analytical methods; Laboratory and packaging equipment qualification; Computer and automated systems involved in testing, manufacturing, materials control; Equipment cleaning procedures; Utilities with product contact; Final approval on Quality / GMP related changes
• Champion cGMP at the plant by organising and chairing local Quality Council that fosters GMP awareness and commitment.
• Ensure and approve local GMP audit activities.
• Serve as primary contact for agency inspectors during regulatory inspections.
• Review of annual product reviews and use data to identify improvements required.
• Maintain oversight of external contactors and activities conducted at other sites by means of quality agreements and audits as applicable.
• Responsible for reporting adverse experiences or events (AEs), adverse device events (ADEs), product quality complaints (PQCs) and other reportable information, customer feedback (CF), alleged counterfeiting, diversion and tampering (CDT) that you become aware of to the Designated Point of Contact DIPOC.
• Ensure adherence to Quality agreements as related to CMOs activities performed by Midrand site
• Support site safety objectives and site portfolio. Promote with QO MPS lean thinking and continuously strive for improvement.
• Prepare annual department budgets and ensure that expenditure is within budget during the year.

Qualifications/ skills

• Degree in Pharmacy or related scientific discipline.
• Knowledge of GMP principles, GDP principles and South Africa GMP requirements (SAPHRA)
• Scientific based decision-making ability.
• Knowledge of QA and Laboratory processes.

Experience required

• At least 6-8 years’ experience leading QA or related pharmaceutical manufacturing functions.
• Knowledge of Computerized systems