This role provides data review support for the Quality Control Department including both release and stability teans supporting validation, testing and reporting of in-process, release and stability samples. Specific assigned persons are responsible to ensure activities occur in an efficient and cGMP compliant manner while fostering the company's vision and values.
- Perform cGMP analytical data review for various techniques such as HPLC, GC, KF, TOC, IR and dissolution to ensure adherence to established methodology, procedures and SOPs
- Review laboratory instrument qualification and requalification packages executed by vendors
- Compile and summarize analytical data in various physical and electronic report formats
- Review laboratory equipment logbooks
- Ensure all laboratory records are accurate and adhere to cGMP/GDP expectation
- May author and review analytical reports, certificate of analysis and SOPs
- Participates in compliance related teams working towards the goal of continuous improvement.
Minimum Qualifications :
- Bachelor Degree in science or related discipline is required. At least five (5) years of experience in GMP pharmaceuticall industry with at least 2 years of data review experience preferably.
- Basic knowledge of US and EU cGMP regulations/guidance.
- Strong knowledge of analytical methodologies such as chromatography, dissolution, and Karl Fisher and applying/interpretation of GMP requirements.
- The ability to work in a fast-paced environment, manage priorities and maintain timelines for multiple projects is essential.