Quality Operations Specialist (6 months contract) - Pharma MNC
- Member of the QO team in ensuring quality oversight at the manufacturing suite
- Partner the manufacturing team in the implementation and adherence to the various quality systems and GMP requirements at the manufacturing suite
- Lead meetings with the manufacturing for information learning/ sharing and alignment of best practices
- Support the compliance, regulatory, inspections and training activities as required and any other responsibilities as assigned by Supervisor
- Revise and participate in the development and writing of procedures pertaining to the QO operations
- Support manufacturing team with development and writing of process standard operating Procedures and master batch records and ensure that it complies with current good documentation practices and the applicable global procedures and regulatory requirements. This includes approval of the associated revision.
- Take on ownership of investigation relating to quality operations.
- Review executed Manufacturing Batch Records (MBR) and approve revision of MBR.
- Participate in cross-functional investigations.
- Support the manufacturing team with any quality interpretation, queries and issues
- The candidate should have at least a degree in pharmaceutical sciences, life sciences, biology, biotechnology chemistry, chemical engineering, or related discipline.
- A minimum experience of 2 years in the pharmaceutical or biotechnology in quality assurance, GMP/GLP compliance, manufacturing operations or validation, ideally in a multinational company.
- Hands-on experience with upstream (e.g cell culture, cell expansion, fermentation, media preparation etc), downstream (e.g purification, column packing, etc) will be of advantage.
- Understanding of FDA/EU and ICH guidelines, any exposure/experience to the international regulatory network will be of advantage.
Interested candidates please submit your resume to [Click Here to Email Your Resume]
Alternatively, pls call Jace at 6736 3280
Jace Choo Oi Kei
Personnel EA License No.: R1875164
Recruit Express Pte Ltd (EA Licence No.: 99C4599)
Recruit Express Pte Ltd