Company:formulation OSD unit

Post : Asstistant Manager ( IPQA -shop floor ) Quality Assurance

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 staffEnsure 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 .

interested candidates can share cv with present ctc, expected ctc, relocation preference

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