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