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02/02 TGI
HR Team at Talent Growth International

Views:263 Applications:43 Rec. Actions:Recruiter Actions:0

Assistant Manager- Process Quality Assurance - Formulation OSD (10-15 yrs)

Maharashtra Job Code: 26061

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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