Title:  Manager -2

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.