Job Description

Role & responsibilities Review and monitoring of day-to-day activities in Quality Control Department . Monitoring the analysis of raw materials, in-process, intermediates and finished product samples which are related to QC. wet and HPLC analysis and its documentation. Responsible for initiation and closing of Incidents, Deviation, OOS, OOT, OOC and Non-conformances materials on timely manner Coordination with other departments for smooth functioning of the Quality control department . storing and recording of control samples, working standards, reference standards and impurities. Review and investigation of CAPA and deviations. Review of the COAs for salable intermediates, finished goods dispatches and approval of analytical reports . Preparation & review of SOPs, Specifications, STPs, protocols and reports etc. Review of Instrument and Equipment qualifications. Performance and review of computer system validations (CSV). Implementing GLP/GMP activities in QC lab Prepare the annual calibration schedules and review the periodic calibration of Instruments. Monitor the stability and holding time study sample analysis and its documentation. Review and approval of Instrument and Equipment qualifications Monitor the activities like storing and recording of control samples, working standards, reference standards and impurities. implement and ensure the compliance of Environment, Health and Safety systems and authorize to stop any environmental damage or unsafe activities. Accountable to meet the EHSMS objectives & minimize the incidents including near-miss In his absence, the immediate superior/same designed shall look after the above activities. Preferred candidate profile : Candidate having Experience in API Quality Control - Dept. having 17 to 20 Yrs of Experience in handling over all QC Functions . Perks and benefits