Quality Assurance Section Head - Compliance

Manage all quality assurance compliance activities including but not limited to GMP and pharmaceutical quality system compliance, gap analysis, internal audits, supplier audits, quality risk management and GMP training.

Duties and responsibilities:

• Prepare, update and train people on procedures relevant to pharmaceutical quality system compliance, gap analysis, internal audits, supplier audits, quality risk management and GMP training.
• Establish risk based annual internal audit schedule, qualify internal auditors, prepares internal audit plans, participate in internal audits, prepare/review internal audit reports, send approved internal audit reports to owners, agree with owners on SMART CAPAs, follow up closure of CAPA and evaluate CAPA effectiveness and quarterly report status of internal audit QKPIs.
• Establish risk based annual supplier / contractor / contract acceptors audit schedule, qualify auditors, prepares audit plans, participate in audits, prepare/review audit reports, send approved internal audit reports to supplier / contractor / contract acceptors, agree with them on SMART CAPAs, follow up closure of CAPA and evaluate CAPA effectiveness and quarterly report status of supplier / contractor / contract acceptors audit QKPIs.
• Ensure that all employees (permanent, temporary) and contractor / visitors receive required GMP training before they independently certified to perform their tasks independently.
• Establish risk based annual GMP training program, prepares a register of qualified trainers, conduct train-of-the-trainer courses, participate in preparation &/or review of training programs, participate in delivery of training programs, participate in evaluation of training effectiveness and quarterly report status of GMP training QKPIs.
• Coordinate all quality risk management activities with cross-functional teams of SMEs, ensure that all site quality risks are assessed, controlled, communicated and reviewed. Follow-up closure of all actions required to reduce risks to an acceptable level and evaluate effectiveness of these actions through after action risk review. Quarterly report status of quality risk management QKPIs.
• Work with cross-functional team to develop and maintain site contamination control strategy. Prepare a quarter report indicating status of contamination control strategy and its effectiveness in controlling contamination and cross-contamination risks and recommendations for improvement.
• Participate in different multidisciplinary teams and relevant activities as required.
• Lead, coach & develop subordinates.

Qualifications:

• 6+ years of experience in pharmaceutical industry including experience in quality operations & in sterile manufacturing.
• BSc in pharmaceutical sciences or relevant discipline.
• Preferable to have postgraduate studies in total quality management.
• Preferable to have certifications such as ASQ CMQ/OE, CQA & CPGP or equivalent.