Quality Control Manager

Job Description

To provide analytical support to the concern department. Releases / Rejection of all raw materials / Packaging material / In-process samples and other samples as per statuary requirement. To organize the availability of resources. Effective implementation of GLP in Quality Control Department. Ensure the updation of Master Specification for RM/PM/FG/SFG/In-process. Ensure the sampling of incoming Raw materials, Packaging materials and Microbiological sampling as per current SOPs. Ensure that the testing of Raw materials, Packaging materials, In-process samples, finished good samples and other samples as per STP. Ensure the calibration of Instruments is completed as per SOP. Ensure the analysis of Rinse (wash water) and swab samples as per plan. Ensuring of documents of Raw Materials, Packaging Materials, In-process samples and Finished Goods as per the statutory requirements. Ensure that all training activities are completed as per SOP. To provide training to the new joiners in QC and other employees. To organize the preparation, maintenance of reference standard & working Standards and documentation as per SOP. To ensure sampling, analysis, and reporting of raw materials, packing materials, finished products, intermediates, in-process, stability, water and routine analysis as per current version of documents. To ensure availability of working standard and ensure the qualification. To ensure Analytical Method Validation and Analytical Method Verification. To ensure availability of current specifications in the laboratory and all the obsolete versions shall be sent back to QA for retrieval. To ensure analyst qualification. To ensure audit trail review in the system. Timely submission of analytical data to QA for the further release of batches. To ensure data integrity throughout the whole process of analysis and reporting. To ensure availability of adequate media, reagents and other necessary requirements for lab and their timely procurement. To ensure the record microbiologist test results in template and verification of the data before its release. To ensure the disposal of tested samples and used media for analysis. To ensure to ensure the environment monitoring of the area (including production area) exposed directly to the product as per their defined frequency and reporting the results. Ensure documentation of preparation and sterilization of media. To ensure that there are personnel with appropriate training and experience in microbiology and knowledge of the process to support the design of the manufacturing process, environmental monitoring regime and any investigation assess the impact of microbiological linked events to the safety of products Review and verify the documentation of OOS, OOT, Laboratory Incident, Deviation, and Change Controls for finished goods, raw materials, In-process, stability, packaging and other materials. Co-ordination with Internal and External agencies for technical support. Ensure the Preparation and Standardization of volumetric solutions / Working Standard is completed on time. To ensure effective implementation of the Quality Management System (QMS) in Quality Control Department with respect to laid down procedures and systems. To ensure that the critical equipments used for analysis are qualified and in calibrated status. To carry out self-inspections and ensure compliance to the audit observation. To ensure the compliance to the current Regulatory requirements and Guidelines. Any other work will be assigned to him as per need.