Department Details
Role SummaryReview of Analytical documents of In process samples, water samples, Raw materials, Packing materials, Intermediates, Finished product, Stability studies, Holding time study samples, Force degradation studies, Working standards, Reference standards, Calibrations, validation studies and analyst evaluation which are related to HPLC, GC and Standalone instruments.• Maintenance, Review and Ensuring Calibration of measuring and testing instruments/equipment’s as per the schedule.• Reviewing /verification of raw data, analytical results against the specifications and respective operating procedures.• Review/Verification of instrument status labels/ status boards.• Responsible to review and release the documents related to intermediates and Finished product within the stipulated time after review.• Review the audit trails for the chromatographic and non-chromatographic systems.• Responsible for the SAP activity.• Responsible for the review of sampling activity.• Review the Calibration and preventive maintenance data of analytical Instruments and equipment • Responsible to investigate the Incidents, OOS, OOTs, OOCs and Deviations occurred across the lab during analysis.• To follow and ensure the Implementation of Corrective Action and Preventive Action across the lab as per the requirement.• Handling/Review of Instrument/Product related logbooks.• Review of protocols, Raw data and reports.• Preparation and review of Quality documents and records.• Review and handling of documents such as Inwards, Instrument logs, column logs and observation data sheets.• Adherence to GLP, GDP and cGMP practices in Quality Control Laboratory.Key ResponsibilitiesReview of analytical instrumentHandling of QMS activitiesLIMSEducational QualificationsRequired Education Qualification: M.ScRequired Experience: 0 – 5 years
