Executive - QC - Instrument

Job Description:

1. Review overall QC documents.
2. Prepare training modules as required and provide training to QC staff.
3. Initiate and approve analyst qualifications as needed.
4. Approve COAs for water analysis from the microbiology department.
5. Review microbiological analytical reports, raw data sheets, and inward registers for finished
products.
6. Prepare and validate Excel sheet calculations.
7. Ensure all necessary testing and calibration are performed as per established procedures and
specifications.
8. Ensure regulatory compliance related to the QC department.
9. Review maintenance records of analytical instruments, facilities, and related documents.
10. Review validation activities, including analytical test procedures, instruments, and calibration
of control equipment.
11. Conduct stability studies as per ICH guidelines and review related records.
12. Update final product specifications as per statutory requirements.
13. Propose new Standard Operating Procedures (SOPs) and analytical instruments, ensuring their
establishment and implementation.
14. Review documents related to reserve retain samples and periodic observations.
15. Review or prepare Certificates of Analysis (COAs) for released finished products.
16. Ensure Annual Maintenance Contracts (AMCs) for instruments are in place with valid
timelines.
17. Verify and confirm electronic data/metadata of instrumental analysis as required.
18. Review and verify chromatograms, audit trails of HPLC/UHPLC/GC/UV/FTIR, and stability
data.
19. Participate in GMP audits and related activities.
20. Review analytical data on a daily/monthly basis and take corrective actions or investigate plant
processes.
21. Handle change control, deviations, and incidents.