Overview
Responsible for Issuance, retrieval, distribution, and destruction of all Quality records related documents. Review of Executed Batch Manufacturing records/ECR and Analytical records. Sampling of Finished product and its respective records, withdrawal of stability sample, hold time sample and other sample as required. Monitoring of packing/repacking related activities and its respective records. Verification of Dispatch activities and QR code approval related records. Ensure that complies with existing SOPs, cGMP/cGLP & plant round. Co-ordinate for data entry in computer. Generation, issuance, and control of label. Preparation and review of PQR of product. Preparation of SOPs and Equipment Qualification protocol and report. Change control issuance, reviewed and evaluation. Verification of external calibration and certification records. Attend training programs organized by the company for continuous training and upgradation of knowledge for complies with existing cGMP/cGLP/safety/IMS guidelines and other relevant information. Preparation of process validation and cleaning validation protocol and report. Calculation to OOT (Out of trend). Perform other work allocated by Designated person. Job Segment:
Quality Assurance, Data Entry, QA, Technology, Administrative, Quality
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Responsible for Issuance, retrieval, distribution, and destruction of all Quality records related documents. Review of Executed Batch Manufacturing records/ECR and Analytical records. Sampling of Finished product and its respective records, withdrawal of stability sample, hold time sample and other sample as required. Monitoring of packing/repacking related activities and its respective records. Verification of Dispatch activities and QR code approval related records. Ensure that complies with existing SOPs, cGMP/cGLP & plant round. Co-ordinate for data entry in computer. Generation, issuance, and control of label. Preparation and review of PQR of product. Preparation of SOPs and Equipment Qualification protocol and report. Change control issuance, reviewed and evaluation. Verification of external calibration and certification records. Attend training programs organized by the company for continuous training and upgradation of knowledge for complies with existing cGMP/cGLP/safety/IMS guidelines and other relevant information. Preparation of process validation and cleaning validation protocol and report. Calculation to OOT (Out of trend). Perform other work allocated by Designated person. Job Segment:
Quality Assurance, Data Entry, QA, Technology, Administrative, Quality
#J-18808-Ljbffr