Sun Pharma Hiring For Manager QA
Title: Manager -2
Date: Dec 10, 2024
Location: Dewas SGO - Quality Assurance
Company: Sun Pharmaceutical Industries Ltd
Job Description
Position: QA Sterile Manager
Department: Quality Assurance
Designation: Manager - II
Education Qualification: M.Sc. in Biotechnology / Microbiology / Chemistry
Total years of Experience: 10+ Years
Job Role: Management of Quality Assurance functions of Manufacturing Block – P.
Responsibilities:
•Ensure that manufacturing and packing of the batch is executed and records are completed and reviewed in accordance with established SOPs and cGMP regulations.
•Conduct certification of batch production records for compliance and stage-wise completion.
•To release / reject the Batch after complete review of batch and related quality documentation.
•Tracking and monitoring of QMS system.
Ensure logical closure of deviations and investigations of related product before release.
•Conduct thorough investigations along with production for any complaints / deviations/ OOS / stability failure for products manufactured at the site and logical / timely closure of Complaints.
•To ensure contamination controls implemented and followed at site as per contamination controls strategy (CCS) and respective procedures.
•Work directly with planning, QC, other QA functions, and Regulatory Affairs to ensure Batches are released to meet supply chain requirements.
•Participate in self-audits of facility and equipment in partnership with Manufacturing and Engineering to ensure readiness for operations.
•Participate in Aseptic simulation (Media Fill) activity, Monitoring and Implementation for PENEM DF.
•Identify continuous improvement opportunities to improve compliance, process clarity, and operational efficiency.
•Review and approve master batch production records (Manufacturing / packing) and SOPs.
•Review and approve equipment qualification & process validation protocols and reports for accuracy, completeness, and traceability as well as adherence to protocol / procedures.
•Review and approve Annual Product Review (APR) reports for the products as per the schedule.
•Stability sample management of finished goods.
•Management of control sample pertaining to collection, review, storage and destruction.
•Management of line clearance, in-process check, coding approval and water sampling.
•Review and approval of IPQA instrument calibration record.
•Management of IPQA activities for Block-Penem.
•Review and approve artwork of Packaging material, STP and Specification.
•Provides appropriate training and development to support staff to meet their respective job responsibilities.
•Work in partnership with Manufacturing, Engineering, and QC to increase knowledge and understanding of cGMPs and improve practices and procedures.
•Review activities related to the Microbiology Laboratory.
•Review activities related to the beta-lactam containment monitoring.
•Compliance with Quality Policy of the organization.
•Improvement of System and procedures, Quality of products manufactured and delivered.
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