Manager - Quality Control

As a quality control professional, you will be expected to strictly adhere to cGMP norms and safety rules within the factory premises. Your key responsibilities will include verifying logbooks, records, and other analytical documents on a daily basis to ensure their correctness and completeness. It will be your duty to ensure the timely preparation and revision of SOPs, STPs, and other Quality Management System (QMS) documents. You will also be responsible for the prompt completion of investigation activities related to Quality Control (QC) aspects such as Out-of-Specification (OOS), Out-of-Trend (OOT), deviations, and out-of-compliance (OOC) activities. Moreover, you will be accountable for the implementation of Corrective and Preventive Actions (CAPAs) as identified, ensuring their completion within the set timelines and evaluating their effectiveness. Additionally, you will prepare and revise calibration and preventive maintenance schedules as per the requirements of the facility. Your role will involve overseeing the calibration of instruments and equipment, both internally and externally, as per the defined schedule and maintaining proper documentation for the same. It will also be your responsibility to review audit trails for all application software used in the QC department to ensure sustained compliance with regulatory standards. Furthermore, you will review documents related to the qualification of working standards and reference standards, ensuring their accuracy. You will also be involved in the preparation and review of protocols for stability studies, instrument/equipment master lists, and quality risk assessments as needed. In the absence of the Deputy General Manager (DGM) or Deputy Chief Manager (DCM) of Quality Control, you may be required to deputize for them and undertake any specific tasks assigned by the Head of Quality. Your role is crucial in maintaining the quality standards and regulatory compliance within the organization.,