IPQA - Officer / Assistant Manager

Zydus Lifesciences; Ahmedabad District; On-site; INR 450,000 - 650,000; Full time

Job summary

Zydus Lifesciences in Ahmedabad district seeks a QA/QC professional to manage line clearance, sampling, and quality-event closures across batch manufacturing and validation. You will verify equipment calibration, coordinate technology transfer, and ensure proper sample handling and disposal.

The role requires meticulous attention to environmental monitoring records and accurate batch documentation to support timely releases.

Responsibilities

• Responsible for providing line clearance prior to Manufacturing, and Packaging and Validation activity during Batch and Product change over.
• Responsible for sampling and in-process checks per defined frequency during batch manufacturing.
• Ensure closure of quality events (Incident/Deviation/Temporary Change Control/OOS) before batch release.
• Verify calibration and cleaning of manufacturing and warehouse equipment.
• Collect swab/rinse samples for micro/chemical analysis and recovery study.
• Ensure timely submission of samples to the QC for analysis.
• Coordinate F&D in technology transfer during exhibit/engineering batch manufacturing.
• Review manufacturing and warehouse area log books and environmental monitoring records.
• Ensure status labelling, segregation of materials as per storage conditions.
• Ensure segregation of rejected material and safe disposal of the same.
• Manage retain sample room and destruction of finished product control samples in LIMS.
• Review executed and Master BMR and BPR and release.

Job description

1. Responsible for providing line clearance prior to Manufacturing, and Packaging and Validation activity during Batch and Product change over.
2. Responsible for sampling and in process checks as per defined frequency and methodology during batch manufacturing of routine Commercial batches, Validation batches and Exhibit batches.
3. Responsible for ensuring the closure of Quality event (Incident/Deviation/Temporary Change Control/OOS) associated with manufactured batch before the batch release.
4. Responsible for verification of calibration and cleaning of manufacturing & warehouse equipment.
5. Responsible for collection of swab/rinse samples for micro/chemical analysis and recovery study.
6. Responsible for ensuring timely submission of the samples to the QC for analysis.
7. Responsible for co-ordinating F&D in technology transfer during exhibit/engineering batch manufacturing.
8. Responsible for review of manufacturing & Warehouse area log books and environmental monitoring records.
9. Responsible for ensuring status labelling, segregation of the materials as per desired storage conditions.
10. Responsible to ensure segregation of the rejected material and safe disposal of the same.
11. Responsible for Management of retain sample room, registration, visual inspection and destruction of finished product control samples in LIMS and environmental monitoring for retain sample room.
12. Responsible for review of executed & Master BMR and BPR and release.