• Ensure the company comply with international pharmaceutical GMP guidelines of regulatory bodies including PIC/S, EMA, FDA and CFDA.
• Ensure compliance of Corporate Quality Policies and Standards in the company and escalate quality and business risks to Corporate Management in a timely manner.
• Compile monthly report on overall company quality issues and propose CAPA for long term improvement purposes.
• Provide guidance on handling quality events following Corporate PQS standards such as Deviation, Change Control, CAPA, Internal Auditing, PQR with the emphasis of the appropriate applications of Quality Risk Management in necessary scenarios.
• Integrate Quality Risk Management to all areas in Manufacturing Operations including product, process and method development or improvement.
• Oversee Quality Risk Assessments in all GMP or regulatory subjects conducted at all manufacturing sites and corporate level.
• Participate in site internal audits to identify potential quality, regulatory and compliance risks associated with Quality Management System, Production System, Laboratory System, Facilities and Utilities.
• Align quality systems across the sites to fulfill quality requirements expected by the Corporate product owner.
• Communicate any confirmed changes such as process, method or material changes associated with the registered products, to support implementation of changes at all sites.
• Take lead in Quality projects as assigned. Engage site risk subject owner, site quality head and Corporate Product Owner Team as Subject Matter Experts to analyze risks and propose scientific and evidence-based mitigation plans.
• Follow through mitigation plans. Perform effective checks on the plans to ensure quality or compliance risks have been managed properly.

 The Person:

• Bachelor of Science or above in Pharmacy, Microbiology, Chemistry, Biomedical Science, or related scientific discipline.
• At least 5 years of pharmaceutical industry experience at supervisory level (preferably with sterile product management experience).
• Possess demonstrated ability to apply QRM in all aspects of Manufacturing Operations.
• Project management experience is highly desirable.
• Possess excellent technical writing and oral communication skills.
• Candidate with less experience may be considered as Assistant Manager.

 We offer attractive remuneration and benefits, 5-day work week, annual leave, medical scheme, comprehensive training and career development opportunities to the qualified candidates.