Location: Kranji MRT
Working Hours: Monday - Friday 8am - 430pm
MIS - Analytical Equipment Qualication experience is a MUST
Job Scope:
This position is required perform all tasks associated with the QC lab operations which includes:
1) Project Management: Analytical, Raw Material and Microbiological Method Introduction
• Able to lead project for Method validation/verification/transfer to introduce new/remediated QC methods for testing existing and new products independently
• Subject matter expert in method validation, verification and transfer; covering wide arrays of methods and complex techniques
• Author of Method validation/verification/transfer Protocols, Reports, Reports, ensuring GMP compliance in ICH Q2(R1), USP <1225>, USP <1226>, EU GMP Chapter 6, and WHO Annex
2) Project Management: Analytical Equipment Qualification
3) Regulatory Filing and Method launches
4) Invalid results tracking, trending and investigation
5) Unexpected results investigation
6) Control Trend establishment and investigations
7) Reference Standard and Reagent qualifications
8) Compendia review
9) Continuous Improvement
10) Audit Preparation and Involvement and other tasks as assigned.
Requirement:
• Diploma/Degree in Chemistry, Biochemistry, Biotechnology
• Minimum experience of 3-5 years in Pharmaceutical, Biopharma or related manufacturing environment
• Prior working knowledge in MIS - Analytical Equipment Qualication
• Basic assay verification/validation know-how
• Knowledge concerning cGMP, especially lab related topics as method validation life cycle, uunexpected results, critical reagent qualification
Interested applicants, kindly submit your most updated resume to [email protected] for consideration.
Jacqueline Jessica Fong Hsin Ting
Recruit Express Pte Ltd (Healthcare & Lifescience)
Company EA License No: 99C4599
Personal EA License No: R21103226
