Senior Executive - QA
On-siteAhmedabad, Gujarat, India
Ahmedabad, Gujarat, IndiaOn-siteFull TimeSenior LevelEnterprise
Full TimeSenior LevelEnterprise
Job Summary
Review analytical raw data, electronic data, and audit trails for laboratory instruments including HPLC, GC-MS, and LC-MS. Investigate and manage QMS events such as OOS, OOT, OOE, deviations, and incidents. Ensure laboratory compliance with GMP/GxP requirements and established procedures. Review, approve, and maintain analytical SOPs, specifications, test procedures, and method validation protocols for continual improvement. Prepare QA department SOPs and impart induction training on GxP compliance to subordinates. Periodically review analytical records, instrument logbooks, and calibration data.
Required Qualifications
- Personnel with Analytical QA background
- Review analytical raw data, electronic data, and audit trails for laboratory instruments
- Ensure laboratory compliance with GMP/GxP requirements and established procedures
- Investigate and manage QMS events- including OOS, OOT, OOE, deviations, and incidents
- Review, approve, and maintain analytical SOPs and quality documents for continual improvement
- Review of analytical raw data and documents
- Review of electronic data and audit trail for instruments like HPLC, GC-MS, ICPMS, LC-MS, XRPD
- Monitoring compliance in laboratory as per laid down procedures
- Investigation of QMS – OOS, Deviation, Incident, OOT, OOE
- Review of Analytical SOPs for compliance requirements and continual improvement
- Review and approval of analytical documents such as specifications, test procedures, analytical method validation / verification protocols & reports, Analytical method transfer protocols & reports, stability reports, investigation reports, trend reports etc.
- Review and approve the raw material, packing material, finished product analytical data
- Review of Product development reports
- Review of computer system validation documents
- Prepare SOPs related to QA Department
- Periodic review of analytical records (instrument logbooks, calibration records, standard management records etc.)
- Impart induction training on topics and on which training has been taken
- Follow GxP (GMP, GDP etc.) for all processes and train the subordinates to follow the same
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