Job Description
• Review quality management systems and approve the documents like SOPs, Protocols, SMF, VMP, QSM, Drawings, batch record, etc and manufacturing IPQA activity.
• Hands-on experience with all conventional and sophisticated analytical instruments.
• Meet qualification and validation activities process and handle deviations, Incidences, change controls, OOS and market complaints.
• Review and update of Site Master File, Validation Master Plan, Quality Manual, Calibration Master Plan and batch record and analysis data and batch release.
• Implementation of training programs and current Good Manufacturing Practices and approve the layouts.
• Conduct, review and Implementation of internal audits. Suggest the CAPA and close the non-compliance report observed during internal audits and review the compliance of both internal and external audits.
• Review, approve and implementation of risk assessment programs.
