Contract Quality Operations Specialist - Pharma MNC (5 days, office hours)
Recruit Express Pte Ltd| Date Posted: 19-May-2020
EA Licence No: 99C4599|EA Personal Registration No: R1875164
Entry Level, Experienced
Bachelor's / Honours
Quality Systems Representative
- 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.
- Take on ownership of investigation relating to quality operations.
- Review executed Manufacturing Batch Records (MBR) and approve revision of MBR.
- Participate as SME in the gap analysis for current SOP/ practices with the various subject matter expert to ensure compliance with revision of global procedures. Where gaps are identified, ensure an implementation/ mitigation plan is in place and follow-through to completion.
- Participate in cross-functional investigations.
- Support the manufacturing team with any quality interpretation, queries and issues
- Render support for timely release of Bulk Drug Substances (BDS) and resolution of BDS release matters
- Provide QO related impact assessments for change controls and own change controls (relating to Quality Pperations)
- Review and approve standard operating procedures
- Lead/ Participate in routine GMP walk-through with manufacturing team
- Participate in all process improvements/studies with the manufacturing team and draft test scripts/ protocols
- Perform timely archival of QO documents
- Manage cell bank and BDS Reference Samples
- Min Degree in Science Related Coruse
- Min 0-1 year of QO/ QC lab experiences in pharma/ lifescience/ biologics/ lab industry
- Able to start work immediately or on short notice Interested candidate
Interested candidates please submit your resume to [Click Here to Email Your Resume]
Jace Choo Oi Kei
Personnel EA License No.: R1875164
Recruit Express Pte Ltd (EA Licence No.: 99C4599)
Recruit Express Pte Ltd