Job Description
Position: QA Sterile Manager
Department: Quality Assurance
Designation: Manager - I
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.
