Skill: qa , change control , capa , quality control , deviation , process validation; Exp: 0-3 years; Primary Responsibilities Handling and management of Analytical QA team activities Responsible to ensure the documents related to Analytical QC are reviewed and approved. Responding to Queries providing support to customer / regulatory on analytical related documents / requests as per the customer / regulatory requirement. Responsible to ensure the effective Review of Method validation, Process validation, Protocols and Reports. Review and approval of analytical reports, Specifications, protocols, QMS investigations generated by Microbiology, VTF and Biologics QC. Handling of Customer Projects and to ensure the documents related to Quality control are reviewed and approved. Review and approval of the Analytical testing records and Final Batch release in SAP. Dispatch approval for all products and issuing the COA as per the requirement. Review and approval of stability summary and stability reports generated by QC. Handling and being part of the investigations related to deviations, laboratory incidents, Out of calibrations, Out of specifications, CAPA and out of trend. Issuance of Documents ( Annexures , ODS , Calibration sheets ,Log sheets etc ) Handling and Management of deviations, Laboratory incidents coordinating in identifying the root cause investigations with CAPA identification, approval and the final approval of deviation. Handling and evaluation of change control, verification and implementation of the corrective and preventive action. Review and approval of the specifications for RM /IP/FP of Biologics, Microbiology and VTF laboratory. Review and approval of working/Lab/Microbiology cultures, Isolates and thawing time of standards COA and the relevant reports. Verification of Instruments operating procedures, IQ/OQ/PQ/DQ of all instruments of QC. Conducting regular GMP rounds in the Quality control Laboratory Performing periodic internal audits to evaluate the performance of the Quality & cGMP systems. Coordinating with the laboratory personnel in handling of the customer queries.
Function: Quality / Process Control