AQA - Executive

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.