Analytical Quality Assurance Specialist
4 weeks ago
Job Title: Reviewer- Analytical QA
Job Overview:
The successful candidate will be responsible for reviewing and approving analytical documents in ELN, LIMS & SAP, ensuring accurate and complete data integrity.
Key Responsibilities:
- Review and approve analytical documents in ELN, LIMS & SAP.
- Perform periodic audit trials for standalone analytical systems and Chromeleon software.
- Handle QA activities related to the Stability Center- QC Late Phase Stability and Early Phase GMP Laboratory.
- Review analytical documents generated at the Stability Center- QC Late Phase Stability and Early Phase GMP Laboratory.
- Ensure adherence to approved written procedures and data integrity policies.
- Conduct regular GMP rounds in the laboratory and participate in customer/third-party audits.
- Ensure compliance with audit observations and notify management of any discrepancies.
Requirements:
- 3-6 years' experience in the pharmaceutical industry as an analyst or reviewer.
- Strong knowledge of chromatograms, non-chromatographic techniques, and analytical methods.
- M.Sc. (Chemistry) or M. Pharma degree.
- Strong analytical knowledge and compliance skills.
Syngene Values:
Excellence, integrity, and professionalism are core values that all employees consistently demonstrate.
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