QC Chemical - Group Lead

As an Associate Manager in the Quality Control Department at ZLL-SEZ Oncology Injectable (Alidac), your role is critical and involves the following key responsibilities: - Plan routine activities of the respective section. - Review all analytical raw data and associated documents for accuracy, including calibration/qualification reports, trend data analysis, and quality control testing protocols. - Report and follow up on any discrepancies noticed during the review process, including deviations and incidents. Perform predictive stability analysis on generated data for stability studies. - Log change controls and ensure proper execution following SOPs. Evaluate proposed changes for impact on safety, quality, and regulatory requirements. - Review post-implementation data for change effectiveness and ensure closure of change controls. Log and investigate deviations, incidents, OOS, OOT, and LIR. - Manage key elements of the Quality Management System (QMS), evaluate root causes, initiate corrective and preventative actions, and track investigation timelines. - Ensure timely sampling and testing of materials, assign samples to analysts, review calibration schedules, and train analysts in quality control functions. - Interact with cross-functional teams and department heads for smooth laboratory functioning. Coordinate with external testing laboratories and maintain laboratory resources. - Uphold instrument/equipment upkeep, laboratory inventory management, and implement project initiatives like Lean Lab. Perform GAP assessment for regulatory compliance. Qualification Required: - MSc - Experience: 10 to 20 years, with 2 to 3 years of experience in Zydus and knowledge of injectable plant operations. For any further information or to apply for the position of Associate Manager in the Quality Control Department at ZLL-SEZ Oncology Injectable (Alidac), please email your CV to vinodg.prajapati@zyduslife.com/HardikA.Bhatt@zyduslife.com.,