Dr Reddy's Laboratories Limited
pharmaceutical
TeamMemberAQA
“Team Member - AQA at Dr Reddy's Laboratories Limited. Skills: Analytical data review, Regulatory Compliance, Data integrity. Review analytical data. Review instrument calibration records”
Industry & Context.
Troubleshoots effectively
What They're Looking For.
Must Have
Graduation in Chemistry/Analytical Chemistry or Pharmacy, 5+ years experience
Nice to Have
Masters in Microbiology, Biochemistry, Biotechnology, Chemistry/Analytical Chemistry or Pharmacy, Experience in ensuring compliance with GMP, GLP, and global regulatory standards, Exposure to executing analytical tests using techniques like HPLC, GC, FTIR, and UV-Vis, Experience in maintaining accurate documentation and ensuring compliance with data integrity principles such as 21 CFR Part 11 and Annex 11, Experience in troubleshooting like Out-of-Specification (OOS) results and non-conformances
What You'll Do.
Review analytical data
Review instrument calibration records
Prepare documentation for stability samples
Perform SAP transactions
Review method validation protocols
Review method transfer protocols
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