Principal Tasks &Responsibilities • Work allocation for sampling , analysis of finish products, returned goods and review of analytical data generated through LIMS / modules and report to Section Head / or HOD - QC. • Review of analysis data of scale up and validation batches, commercial batches of finished product and also of raw materials/ packing materials / in process/ Intermediate / hold time/ stability study and reference standard management analysis data. • Analytical support to Regulatory department whenever required. • Responsible for validation of analytical method / method transfer as per regulatory requirement and for validation of cleaning analytical method. • Responsible for calibration, maintenance and trouble shooting of instruments and ensure the calibration and maintenance performed as per schedule and laid down SOPs with documentation and updating of instrument calibration status tag. • To approve the analytical data reviewed by second person of finished products /intermediates and raw material after completion of analysis as per regular specification. • To ensure the every analysis is to be analyzed as per current version of specification and method of analysis. • To ensure that all the analysis as per customer specification is done (for dispatch) as per the planning (planning to be taken as per delivery instruction) and ensure completion of analysis in time with all documentation. • To ensure all records / documents are maintained in compliance to regulatory requirements. • To ensure all the entries, records and results are in line with current specifications and STPs and review and approval of reviewed certificate of analysis for raw, packing material / intermediate and APIs. • Ensure daily on-line entry in SAP and LIMS modules. • To maintain instrument history record. • Monthly project creation verification and verification of back up restore of electronic / software generated analysis data. • Co-ordinate with service engineer regarding break-down and preventive maintenance of equipments or facility. • Review of outside laboratory certificate of analysis. • Ensure CFR-21 –Part 11 practices are followed effectively with online documentation and periodic review of audit trials for the computerized system / instruments. • Ensure that all documents / records required for Regulatory Compliance are maintained properly. • Review of SOPs and revision for Regulatory compliance to inline with current guideline. • To ensure the analytical documents like specification, protocol, STP, are prepared as per SOP. • Ensure timey report and completion of NQI, QI, OOS, OOT, deviation, customer / market complaint investigation and change control. • Ensure all issues related to completed batches are resolved and documents are transferred to QA. • To maintain instruments usage logbooks properly as per analysis. • To maintain the GLP and GMP practices & ensure standards procedures in Quality Control laboratory followed effectively. • To review the Standard Operating procedures, work sheets/protocols of Hold time / stability / validation / qualification and other relevant documents of Quality control depart • To co-ordinate with QA department for cGLP system • To co-ordinate with production department for on line analysis by proper planning/clubbing of analysis. • To co-ordinate with store department to prior information of urgent analysis of raw material. • To coordinate with EHS for safety and environment related concern.
