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. Upon completion, review and ensure closure of changes.
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.
Draft, compile, review and update appropriate procedures and listing relating to GMP and operational quality.
Lead or participate in investigations arising from customer complaints, returned goods or product failure
Min. Degree in relevant science discipline.
Min. 1-2 years of relevant experience in the pharmaceutical industry
Knowledge on GMP, validation, quality and manufacturing processes.
Good knowledge of corporate management systems and regulatory processes
Excellent interpersonal and communication skills
GMP Technologies (S) Pte Ltd | EA Licence: 11C3793 | EA Personnel: Fiona Koh | Registration No: R1109239