PURPOSE

To provide quality oversight for manufacturing operations and ensure full compliance with current Good Manufacturing Practices (cGMP) and regulatory requirements, so as to meet stipulated product quality standards in line with the established specifications of the organization.

RESPONSIBILITIES:

• Assess, review and approve all cGMP related documentation
• Review batch and quality documentations to assess whether the product is fit for purpose prior to making usage decision
• Assess, review and approve changes that may have an impact on product quality, validation and/or cGMP compliance to ensure timely product release to customers. Upon implementation of changes, review and ensure proper closure of changes.
• Inspect and release process equipment/plant after turnaround.
• Co-ordinate, review and approve Periodic Reviews of products, systems and processes.
• Conduct and support site audit inspection preparation and participate as an audit team member in audits, including internal and external audits
• Draft, review, update and be subject matter expert for appropriate procedures and listing relating to cGMP, site supplier management, and operational quality and ensure they are in full compliance with cGMP and GSK requirements.
• Support shift operations which include production, engineering, laboratory etc. to provide the necessary quality oversight in terms of activities such as change control, deviation investigation eg. Initial impact and remedial action assessment
• Provide quality oversight of shift operations, laboratory and engineering team in all aspects of GMP, not limiting to regular walk downs to production facilities including supporting areas with the necessary coaching of the shift staff. These areas include but not exclusive to production buildings, laboratories, engineering buildings and storage facilities.