Analytical Quality Assurance Specialist

4 weeks ago


Bengaluru, Karnataka, India Syngene Full time

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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