JOB RESPONSIBILITIES 1. Preparation of New product documents and Routine Revision of Raw Material Specifications and Standard Test Procedures for Export, Regulatory agency and Domestic market. 2. Preparation of New product documents and Routine Revision of Finished Product Specifications and Standard Test Procedures for Export, Regulatory agency and Domestic market. 3. Preparation of Specification and Standard Test Procedures for Drug controller general of India permission for Domestic market and Export market. 4. Preparation of Specification and Standard Test Procedures for Food and drug administration permission for Domestic market. 5. Preparation and revision of Specification and Standard Test Procedures as per pharmacopoeial updation for Export and Domestic market. 6. To coordinate with Formulation and development, Quality Control and Regulatory Agency 7. Taking the Backup record of Raw material, Finished Product Specification and Standard Test Procedures. 8. Responsible for issuance of control copies including specification/Standard Test Procedure/General Test Procedure to QC department. 9. Maintain GLP in the laboratory as per regulatory requirement. 10 Issuance and Maintain the records of reference standards, working standards and impurities standards 11 Issuance and Maintain the records of HPLC columns 12 Calibration of all laboratory instrument/Equipment likewise HPLC/Dissolution/UV/FTIR/GC/LCMS-MS/Autotitrator/Analytical Balance 13 To perform daily calibration of Instruments/Equipment likewise Analytical Balance, pH meter, Temperature record for Refrigerator and thermometer etc. 14 Preparation and revision of Analytical laboratory’s SOP. 15 Issuance and Maintain the records of LNB for validation group, development groups. 16 Issuance and Maintain the records of MRS for development groups. 17 Indent generating of all laboratory Impurity Standard, column chemical, solvent, Glassware, stationary, Instrument Spare etc. 18 Review and update the monthly records for HPLC Utilization. 19 Training of new comers and subordinates with records keeping.
