Job Responsibility:

- Responsible to review Analytical method validation, Analytical method transfer protocol and reports. To ensure that all the instruments used for analysis are in calibrated state.
- Responsible for reviewed incident and closure.
- Responsible for login of OOS, OOT & OOC and review 1st phase investigation.
- Responsible for review stability analysis data and preparation stability analysis summary report.
- To review completed ATDS & Laboratory control records before release of the API for distribution.
- Responsible to review audit trial of the QC, Microbiology Lab instrument and to ensure appropriate method utilized during analysis of the material.
- To handling of QMS documents. i.e. Deviation, Market Complain, OOS, OOT, Incident & CAPA.
- To ensure cGMP compliance in Quality Control & Microbiology Laboratory.
- To review Batch Manufacturing, Equipment Cleaning and relevant records.
- Responsible to approve or reject intermediate/second crop.




- Responsible to review audit trial of the QC & Microbiology Lab instrument and to ensure appropriate method utilized during analysis of the material.
- Responsible to review of data in the chromatographic and non-chromatographic system.
- Responsible to ensure that all materials are appropriately tested and the results are reported.
- Responsible to impart training on cGMP, GLP and other trainings as required.
- Approval for Re-integration authorization in absence of approved authorizes.
- COA Approval for immediate action in absence of approved authorizes.
- To perform internal audit (Self inspection) /external audits and provide compliance report for internal/external audits.

- Responsible to carry out other activities as instructed by Head-QA.
- Responsible to approve, release or reject of intermediate, bulk and finished product.
- Responsible for review of QC ,Microbiology Instruments/Equipments qualification and CSV.

📌 AQA - Executive (Vadodara)
🏢 Exemed
📍 Vadodara