QA Sterile Manager

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.

Skills Required

Microbiology Laboratory, Sops, equipment qualification , Process Validation