Review documents / analytical test results and assess all attributes/elements contributing to product release to determine if product / equipment is fit for release.
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.
Inspect and release process equipment/plant after turnaround.
Assess, review and approve all cGMP and validation related documentation. Be a subject matter expert for operational quality processes.
Co-ordinate Periodic Product Review (PPR) activities and compile the report.
Lead or participate in investigations arising from customer complaints, returned goods or product failure etc, and accurately assess the impact of the complaint/failure/investigation so as to make appropriate recommendations on remedial actions for follow-up.
Participate as an audit team member in the preparation of site audits by corporate and external groups such as the Food and Drug Administration (US), Health Sciences Authority (HSA)
Draft, compile, review and update appropriate procedures and listing relating to GMP and operational quality.
Update Technical Terms of Supply/Quality Agreement and issue Technical Terms of Supply/Quality Agreement change control to customer as needs arise.
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 etc. for the manufacture and testing of the products.
Conduct regular walk downs to production facilities including supporting areas. These areas include but not exclusive to production building, laboratories, engineering building and storage facilities.
Min. Degree in a relevant science discipline.
With 2-5 years of relevant experience in the pharmaceutical industry.
Good knowledge on GMP, validation, quality and manufacturing processes.
Good knowledge of corporate management systems.
Good audit skills.
Detailed knowledge of regulatory processes
Able to perform 12 hours rotating shift work
GMP Technologies (S) Pte Ltd | EA Licence: 11C3793 | EA Personnel: Fiona Koh | Registration No: R1109239