Quality Assurance - IPQA, QMS (Officer/Sr. Officer/ Executive) Navsari

Role & responsibilities

IPQA:-

1. Responsible for line clearance and in process checks of Production.
2. Responsible for Sampling of in-process, Finished Product, control samples, stability samples, and Process Validation samples as per procedure.
3. To ensure online rejection activities and environment monitoring in manufacturing and packaging areas.
4. To conduct periodical log review.
5. To review of batch documents (Batch Manufacturing, Batch Packaging records, and Quality Control analysis data of the batch).
6. To ensure online documentation during manufacturing and packaging area.
7. To prepare and review of Quality Assurance Standard Operating Procedures.
8. To ensure Re-processing and Re-packing activity.
9. Responsible to perform Acceptance Quality Limit and Pre Dispatch Inspection of finished product.
10. Responsible for preparation of Annual Product Quality Review.
11. Responsible to maintain the document as per current Good Manufacturing Practices.
12. Responsible to initiate Change control\Deviation\Incident\Market complaint\non-conformance investigation.
13. To assist the Head of Department for preparation of regulatory inspection.
14. Any other responsibility assigned by Head of Department.

Quality Management System:-

1. To coordinate with cross functional department for execution of training planners and maintain training record for same.

2. To master, issue and retrieve of SOPs/BMR/BPR/QC dockets and other documents in-line with the laid down procedure.

3. To maintain vendor related documents and conduct vendor audits.

4. To investigate and prepare Market Complaint investigation report.

5. To take follow up and communicate with customer/vendor regarding Complaint.

6. To handle Change control/Deviations/Incidents/NCR/CAPA.

7. Review of quality technical agreements.