Quality Control Manager/Sr. Manager

Job Description

QC Manager/ Sr. Manager Job Responsibilities Training to staff for following practices as per standard operating procedure, Good Laboratory Practices and Pharmacopoeia / in-house method of analysis To monitor data integrity in Compliance of good laboratory practice and Compliance of GMP in the Quality Control Laboratory. To check and sign Certificate of Analysis (COA) for export as well as domestic. To review and ensure Deviation, Corrective action Preventive action (CAPA) report, Market Complain Investigation related activity and its implementation. To review risk assessment and appropriate measures to mitigate the risk and to prevent reoccurrence of risk. Ensuring effectiveness and applicability of the QA system through self-inspection and Quality audit. Improvements / revision in Standard operating procedures as per procedure and their implementation from time to time. To monitor retain samples/logs and physical observation as per standard operating procedure. To monitor stability samples, test frequency and summary results. Monitoring of necessary testing being carried out timely as per specifications and method of analysis and release of certificate of analysis. To monitor maintenance/ repairing of instruments and their annual maintenance contract from external agencies. Co-ordination with public testing labs for timely test report. Getting technical agreement with them, pay visit at time of test to monitor correct method of analysis, whenever necessary. Interdepartmental co-ordination for smooth working to reduce down time in mfg. & packing of various products. To manage for incidents for all testing related chemicals/ apparatus/ standards/ media/ accessory/ parts/ books/ stationary/ dress/ men power requirement, new machine requirement. etc, for timely testing for API/ excipients/ In-process/ finished products/ stability samples etc. Supervision, guidance and inspiration to down the line colleagues for improvement of systems with respect to quality/ data integrity/ efficiency/ correct work procedure etc. To investigate Out of Specification/Out of trend and take appropriate corrective action and preventive action as per standard operating procedure. To prepare risk analysis documents and monitor for probable risks in testing/ reporting, train staff accordingly. Active participation in technology transfer and validation exercise. Evaluation and monitoring of trend data. Monitoring soft data management. To Review and Approved Finish Product (Injection/API), Raw material, Packing material Specification, Standard Operating Procedure, Analytical Work record. To release and approved Raw material / Packing Material in SAP system along with Certificate of analysis (COA). To approved Certificate of analysis (COA) and Release the Semi-finished & Finish product in SAP system. (i.e. I1 and A1) To conduct internal audit / External Audit / self-inspection to ensure compliance to GMP and other regulatory