HR Team at Talent Growth International
Views:156 Applications:27 Rec. Actions:Recruiter Actions:0
Assistant Manager- Process Quality Assurance - Formulation OSD (10-15 yrs)
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 .