Analytical QA Specialist
4 weeks ago
Job Title: Reviewer- Analytical QA
Job Summary:
We are seeking a highly skilled Analytical QA Specialist to join our team at Syngene. As a key member of our Late Phase Stability and Early Phase GMP Laboratory, you will be responsible for reviewing analytical documents and ensuring compliance with company standards.
Key Responsibilities:
- Review and approval of analytical documents in ELN, LIMS & SAP
- Periodic audit trial review for all standalone analytical system and Chromeleon software
- Handling of QA activities related to Stability Center- QC Late Phase Stability and Early Phase GMP Laboratory
- Review of data generated at Stability Center- QC Late Phase Stability and Early Phase GMP Laboratory with respect to its correctness, authenticity, completeness and other aspects of data integrity as per Data Integrity policy
- Complete required training and qualification before performing an activity
- Review of raw data/online sequence, chromatograms for method parameters, integration, and calculation
- Performing review/approval related activity in Laboratory Information Management System (LIMS), ELN & SAP
- Issuance of logbooks and other documents (Annexures, ODS, Calibration sheets, Log sheets etc.) and allocation of instrument numbers, format numbers
- Conducting regular GMP rounds in laboratory
- Co-ordinate & participate during customer/third party, cGMP audits, regulatory audits and internal quality audits. Ensure compliance with the audit observations
- In case of any discrepancy, immediately notify to the reporting manager or his designee or Head or designee GMP Analytical Laboratory
Requirements:
- 3 - 6 years' experience in Pharma industry as analyst or reviewer
- Demonstrated Capability
- Should have strong knowledge in Chromatograms, Non-chromatographic and all analytical techniques in Pharma industry
- M.Sc. (Chemistry) or M. Pharma
- Should have strong analytical knowledge
- Should have strong chromatographic & non-chromatographic technique knowledge like HPLC, GC, IR, UV, NMR, XRD, ICPMS, GCMS, etc.
- Should have strong compliance knowledge in Data integrity and other pharmacopeia guideline USP, EP, ICH, etc.
Equal Opportunity Employer:
Syngene is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive work environment that values diversity, equity, and inclusion.
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