- Develop analytical method transfer and/or validation protocols, leads execution and ensure closure to requirements.
- Lead and execute analytical change control and ensure the change control is implemented in accordance to site procedures and cGMP requirement.
- Conducts review and coordinate implementation of compendial methods and MSD Quality Standards and provides analytical input to CMC or related regulatory enquiries in support of regulatory filing.
- Lead and perform lab system validation and maintain the system in accordance to system development lifecycle and cGMP requirements.
- Develop and prepare site analytical test procedures, stability protocols and ensure stability programs are administrated in accordance to regulatory and MSD Quality Guidelines.
- B.Sc in Chemistry with 5-7 years of experience in Pharmaceutical industry.
- Good knowledge and understanding of GMP.
- Experienced in analytical method transfer, use of LIMS and Empower is highly preferred.
- Good knowledge and application of Lean and continuous improvement mindset.
Job: Quality Lab Related Job Title:Spclst, Quality Control
Primary Location: APAC-SG-Singapore-Singapore
Employee Status: Regular
Number of Openings: 1
Company Trade Name:MSD
Job Segment: Laboratory, Law, Pharmaceutical, Science, Legal