Assistant Manager- Process Quality Assurance - Formulation OSD
Talent Growth International
Maharashtra
Permanent
Full-time
1 month ago
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 floorEducation : B.Pharma / M.Pharma/ B.Sc./M.ScCompensation : At par with the IndustryDepartment : 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 .