Associate QA Director

Main Duties:

• Establish a robust quality management system (QMS) and execute quality oversight to make sure all GMP management programs and operation processes are compliant to cGMP requirement, e.g. 2010GMP, EUGMP and 21CFR Part 211.
• Review and approve validation master plan, equipment qualification protocol and report to ensure equipment/instrument/computerized system are qualified or validated before use.
• Familiar with requirements of GAMP 5.
• Review and approval all technical documentation, e.g. process flow diagram (PFD), master batch record and make sure all CPPs are identified with scientific rational and all production operations are consistent with requirements of technical document.
• Review and approve all laboratory documentation including analytical instrument qualification protocol, method validation/verification, test work sheet etc.
• Oversight the execution of site deviation and change control program and involve in review of deviation and change control report to ensure patient safety, product quality and data integrity.
• Coordinate site QMS continuous improvement by a couple of GMP operations, e.g. site self-inspection (SSI), deviation CAPA execution and change control implementation.
• Work as a sponsor of date integrity management, identify potential integrity risk and prepare actions to minimize or mitigate risk.
• Monitor current regulations, coordinate gap assessment and execute improvement actions accordingly.
• Coach or train site employee to improve their GMP awareness and technical capability.

Minimum Requirements:

• Bachelor degree or above with major of science of pharmacy or relevant
• At least 10 years’ working experiences in QA, production or QC area of pharmaceutical manufacturing site(MNC manufacturing site is preferred)
• Solid GMP knowledge of oral dosage drug product and well understand requirements of current cGMP of US, EU and China.
• Strong capability of leadership and strategic thinking
• Good communication skills
• Fluent oral English and Good written English