Analytical Quality Assurance (AQA)- Sr. Executive

Overall implementation of Quality System.

Approval of Quality Documents (SMF, VMP etc..,)

Approval of Standard Operating Procedures.

Approval of Drug Master Files.

Approval of Master Formula Records.

Approval of Master Batch Manufacturing Records / Blending and Packing Records.

Authorization of Raw Material / Packing Material / In process / Recovered Solvents / Intermediate / Final API specifications & MOAs.

Authorization of Reprocess / Rework procedures.

Releasing / Rejecting RM / Intermediates / API analyzed due to retest.

Releasing / Rejecting Intermediates

Releasing / Rejecting Final APIs.

Approval of the new vendor samples.

Approval of the Vendor Questionnaire

Conducting Vendor Audit

Approval of new vendor & Vendor Evaluation

Approval of the Approved Vendor List and Vendor Rating.

Approval / Rejection of Change controls.

Approval / Rejection of deviations.

Investigation of Out of Specification (OOS) for the Raw material / Packing Material / Intermediate / Final API.

Review & Authorization of PO Intimation form.

Compliance for calibration of all the equipments / instruments

To lead and approve the validation / qualification activities at the site. Review and approval of process validation, blending validation, cleaning validation, temperature mapping, equipment qualification & other validation protocols & reports.

Review and Authorization of the executed BMRs, BPRs, Reprocess / Rework BMRs & laboratory control records of critical process steps before release of the API for distribution.

Release / Dispatch of products manufactured

Authorization of Certificate of Analysis

To investigate and resolve Quality related complaints.

Authorization of Returned/ Recalled/ Rejected Goods

Review and approval of the corrective & preventive action reports.

To take lead during internal audit.

Ensuring internal quality / regulatory / customer audit being performed and compliance for the observation done by regulatory / customer.

Review and approval of Periodic Product Review Reports, General Annual Review Reports & Annual review reports.

Carrying out audits for external laboratories and service providers

Conducting and providing training for all the personnel.

Organizing for Management review meeting.

Review & approval of filled customer questionnaires.

Approval of Objectives of all the departments

Any other responsibility as and when delegated by Management.