Job Description :

- Provides leadership, mentoring and development opportunities for the IPQA staff.

- Ensures IPQA are appropriately trained and aligned to support plant operations.

- Aligns with site goals and ensures IPQA staff is supporting Quality, Compliance and Production objectives, focused on Quality Throughput.

- Provides Strategic direction to the In-Process QA group in alignment with site and QA objectives, to ensure that business and compliance needs are met.

- Ensure the IPQA staff is available and active in first response to product quality issues for all shifts.

- Ensures product, facility, and equipment holds are placed when batch, equipment or systems are potentially impacted.

- Provide Line clearance in every step of manufacturing prior to commencement of manufacturing and during change over.

- Ensure the materials are dispensed as per the standard quantities mentioned in the BMR.

- Online checking of In-process parameters.

- Carry out sampling of In-process, Finished Product, Stability and Retention samples for the commercial and validation batches after receiving intimation from production department and submitting to QC.

- Online Review / Checking of Batch Manufacturing and Batch Packaging Records.

- Ensure the process is being manufactured as per the BMR & BPR.

- Monitor all Shop floor activities.

- Monitor Cleaning and Sanitation Procedures.

- Ensure manufacturing areas and their premises are maintained as per cGMP.

- Responsible for overall management of IPQA activities.

- Responsible for coordination with Production/R&D/QA/QC for various activities.

- Ensure GMP compliance at shop floor as per respective SOP's.

- Compliance verification of SOP's of QA/Production/Warehouse.

- Ensure the Timely review of Executed BPR's.

- Review of in process testing and executed batch production record.

- Preparation, review and approval of sampling matrix and hold time schedule.

- Training of all the IPQA staff.

- Ensure that all equipment is calibrated.

Additional information :

Experience : Minimum 10 years of experience in core IPQA shop floor section of pharma OSD formulation mandatory .Industry Type : Pharmaceutical OSD (formulation )

Functional Area : IPQA-shop floor

Education : B.Pharma / M.Pharma/ B.Sc./M.Sc

Compensation : At par with the Industry

Department : Quality Assurance (IPQA shop floor)

Location : Raigad. Should be comfortable in marathi and ready to relocate to Maharashtra . Immediate joining / within 30 day after rollout offer joining candidates preferred .

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