1. Review analytical data for Raw Materials (RM), Packaging Materials (PM),
in-process samples, Finished Products (FP), stability samples, working
standards, reference standards, and other test samples.

2. Review and approve Certificates of Analysis (COAs) for RM, PM, in-process
samples, FP, stability working standards, reference standards, and other
test samples.
samples.

3. Review SOPs, STPs, specifications, and other laboratory documents.

4. Verify the accuracy of data entered in LIMS and manual documentation
systems.

5. Review protocols and reports related to analytical method transfer,
validation, verification, and waiver activities. Review analytical raw data
associated with method transfer, validation, and verification studies.

6. Review and approve daily verification, calibration, and qualification
records of laboratory instruments and equipment.

7. Review and approve Computer System Validation (CSV) documents.

8. Review instrument logbooks, calibration records, and third-party
calibration reports.

9.



Review and approve the audit trail reports for Empower and non-CDS systems.

10. Review stability schedules, stability protocols and stability reports.

11. Ensure data integrity and compliance with ALCOA principles and
documentation practices. Verify analytical records for compliance with GLP
and cGMP requirements.

12. Review investigations related raw data and report i.e. OOS, OOAL/OOT,
deviations, incidents, and change controls.

13. Review vendor qualification reports and related documentation.

14. Review reduced testing reports and related documentation.

15. Review analytical data and COAs received from contract testing
laboratories.

16. Review and approve preparation records of reagents, mobile phases,
diluents, impurity solutions, and other laboratory solutions.

17. Review analytical raw data for analyst qualification and approved.

18. Verify compliance of laboratory activities through documentation review.

Additional Responsibilities:

📌 Senior Executive, Lab QA (Ahmedabad)
🏢 Amneal
📍 Ahmedabad