Officer - Quality Assurance (IPQA)

Role & responsibilities

Candidate should have experience of Injectable plant only.

Responsible for line clearance and in process checks of Production.

Responsible for Sampling of in-process, Finished Product, control samples, stability samples, and Process Validation samples as per procedure.

To ensure online rejection activities and environment monitoring in manufacturing and packaging areas.

To review of batch documents (Batch Manufacturing, Batch Packaging records, and Quality Control analysis data of the batch).

To ensure online documentation during manufacturing and packaging area.

To prepare and review of Quality Assurance Standard Operating Procedures.

To ensure Re-processing and Re-packing activity.

Responsible to perform Acceptance Quality Limit and Pre Dispatch Inspection of finished product.

Responsible for preparation of Annual Product Quality Review.

Responsible to maintain the document as per current Good Manufacturing Practices and conduct periodical log review.

Responsible for issuance of Batch Manufacturing Record and Batch Packing Record to the production department as per the production planning and allocate batch number to the product as per SOP.

Responsible for initiate and handling of Change Control/Deviation/Non-Conformance /Incident and Market Complaints Investigation / CAPA / OOS phase II investigation.

To assist the Head of Department for preparation of regulatory inspection.