Senior Officer

3 days ago

Paonta Sahib Himachal Pradesh, India Sun Pharmaceutical Industries Full time

Job responsibilities Monitoring In-process monitoring of Manufacturing Packing activities of Tablets and Capsules Ensure compliance to cGMP Regulations established SOPs FO MI and PO PI and for all operational activities area and equipment s Perform QA review of executed batch production records and ensure the submission of Batch production record in the document cell Calibration maintaining documentation of In-process Quality Assurance IPQA instruments Data back-up activities for IPQA instruments as per defined SOP frequency Monitor the environmental conditions mentioned in the batch production record and SOP Certification of batch production records for compliance and stage-wise compliance Reporting any GMP related discrepancies non-conformances and deviations to superiors immediately Collection and entry of data for APR preparation Imparting training to subordinates Line Clearance Ensure physically that the area and equipment to be used for manufacturing and packaging of next product batch are free from any material remnants of previous product Ensure to prevent mix up and cross contamination Check for proper environmental conditions with respect to temperature Relative humidity differential pressure etc Ensure that the Batch Production record is completed up to the previous stage Verify the material with respect to the container labels and quantity from the batch production record In-Process Checks Ensure the calibration of instruments for in-process checks In-process checks as per the approved manufacturing and packaging instructions Enclose all the printouts generated during in-process checks along with the batch production record All printouts shall be duly signed after checking Inform the production manager supervisor and quality assurance manager about the in-process failure observed during in-process checks To record all the observations in the Batch Production Record Inspection Inspection of the Bulk Tablets Capsules as per respective SOP Inspection of the Finished Goods inspection as per SOP and clearance of Transfer Ticket by ensuring the quantity and batch details Sampling Ensure for usage of appropriate sampling tool for sampling Ensure sampling device cleaning prior to the sampling Sampling procedure to be followed as per SOP Ensure sampling of in-process finished product process validation cleaning validation control samples EU Lab testing samples stability samples as per SOP Approval Approval of coding pattern on immediate pack and secondary pack to be verified as per the approved packaging instructions written procedures

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