Senior Executive AQA

Roles & Responsibilities

Perform activities as per safety precautions, cGMP, and adhere to Quality Policy.

Perform and document activities as per good documentation practices (GDP) with data integrity.

Verify laboratory ambience for a clean and safe workplace.

Verify analytical instrument calibration.

Ensure continuous training and development of team members.

Prepare, review, and maintain standard operating procedures.

Prepare and review specifications and standard testing procedures for products.

Review test data sheets.

Review audit compliance reports and ensure effective implementation.

Review events, incidents, OOT, and OOS.

Review controlled documentation systems in QC department.

Assist in writing, revising, and verifying quality standards, procedures, and forms.

Record, evaluate, and report quality data.

Execute and monitor analytical QA-related activities.

Prepare and conduct QA-related training.

Review analytical deviations, PNCs, OOS, and change controls.

Review investigations related to product complaints and OOS, and implement preventive actions.

Review certificates of analysis.

Review aberrant results.

Review trend analysis reports.

Review stability protocols.

Review GMP documents like SOPs, protocols, schedules, specifications, STPs, and GTPs.

Review vendor qualification documents related to QC laboratory.

Review validations and verifications to be performed.

Review qualification documents.

Review activities related to process validation, method development/transfer, hold time studies, and validation reports.

Record temperature in control/sample rooms.

Conduct and support internal audits, self-inspections, and contract analytical site audits.

Conduct vendor audits.

Verify reference and retention samples.

Perform sampling and release of raw/packing materials.

Verify receipt and segregation of raw/packing materials.

Supervise sampling, testing, and dispensing of raw/packing materials.

Perform water sampling and analysis as per schedule.

Control raw data (collecting, storing, issuing, retrieving, destroying documents).

Perform documentation control.

Arrange and coordinate documentation cell activities.

Review training programs/documents like SOPs, STPs, specifications, and protocols.

Issue and retrieve controlled documents (SOPs, formats, analytical data, protocols, etc.).

Execute other jobs assigned by HOD outside defined responsibilities.

Monitor transportation of samples to external QC laboratories as per transport validation.