Senior Executive

Review of analytical data of scale up and validation batches, commercial batches of finished products and also of raw materials, packing material, in process, intermediate, hold time study, stability study and working standard. Review of system audit trail and review of electronic data (Comparison of hard copy and soft copy) To ensure the every analysis is to be performed as per predefined approved / 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 all dispatches in time with all documentation. Monitor and Maintain records of Training, analyst validation and competency. 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. Review of outside laboratory certificate of analysis. Ensure CFR 21 part -11 compliance and good chromatography practices followed during analysis, & review for proper of chromatographic analysis to maintain proper data integrity Ensure that all documents / records required for Regulatory Compliance are maintained properly. Review SOP s for regulatory compliance and actual practice. Ensure timey report and completion of NQI, OOS, OOT, deviation, customer / market investigation and change control. Ensure all issues related to completed batches are resolved and documents are transferred to QA. To revise the SOP/STP as per schedule To maintain instruments 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 department. To co-ordinate with QA department for cGLP system To co-ordinate with production department for on line analysis To co-ordinate with production department for planning/clubbing of analysis. To co-ordinate with store department to prior information of urgent analysis of raw material. Prepare and submit reports as required. To ensure the storage of lab chemicals and test samples at proper place with segregation to prevent accidents."