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1.Responsible for accountability of cGMP compliance. 2. Responsible for ensuring implementation of SOPs in day-to-day activity. 3. Responsible for all compliance in Quality Assurance Department 4. Responsible for review and execution of all type of Validations. 5. Responsible for complete Functions of Quality Assurance Department. 6. Responsible for Review and Approval of all SOPs / STP and specification. 7. Responsible for Review and Approval of all protocol & report of AMV, PV, Stability, cleaning validation, area validation , water validation and other utility validation etc. 8. Responsible for Internal audit/self Inspection and External Audit. 9. Responsible for implementation of good documentation practices. 10. Responsible for implementation of Data Integrity practices. 11. Responsible for handling of change control, deviation, incident, CAPA, out of specification, out of Trend & online rejection. 12. Responsible for implementation of corrective and preventive action. 13. Responsible for handling of Risk Management. Responsible for continuous training programme Responsible for Vendor Qualification Responsible for Mock recall/Product Recall Responsible for Handling of Market Complaint and Investigation. Responsible for handling and Approval of Change control, Deviation, incident and CAPA Approval of all departmental organograms, Job descriptions, Site Master File (SMF),Validation Master Plan (VMP),Calibration Master Plan (CMP), Quality Manual. Responsible for Approval of Batch Process Record. Approval of RM and PM Sheets for batch manufacturing. Responsible for Batch Release Execution and verification of all process validation batches pertaining to parenterals and OSD formulations. Handling of Internal & External audits (Regulatory Audits) with respect to renewal of product license or cGMP audit. Responsible for Preparation of audit compliances report against the internal/external audit observations. Responsible for Approval / Rejection of Finished Product. Any other responsibility given by Management.