Quality Control Manager/Sr. Manager

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