Description:Major Responsibilities: \xc3\x98 Quality Management System Implementation and Modification control. \xc3\x98 Document Control. \xc3\x98 Approval for batch release. \xc3\x98 Review and approval of Qualification Document. \xc3\x98 Review and approval of Calibration and Validation document. \xc3\x98 Planning, execution and compliance of both internal and external audits. \xc3\x98 Preparation of audit compliance report. Job description Minor Responsibilities: \xc3\x98 Review and approval of SMF, VMP and Quality manual. \xc3\x98 Review and approval of BMR, BPR, MFC. \xc3\x98 Review and approval of OOS/OOT. \xc3\x98 Review and approval of Vendor list. \xc3\x98 Planning, execution and compliance of both internal and externalaudits. \xc3\x98 Review and approval of all Quality Assurance, quality Control and manufacturing records. \xc3\x98 Review of filled BMR/BPR and analysis data, and release of batch for dispatch. \xc3\x98 Review and approval of SOPs. \xc3\x98 To prepare audit and compliance reports and CAPA reports. \xc3\x98 Review and approval of Qualification Documents. \xc3\x98 To review and approval of Change control. \xc3\x98 Review and approval of Deviation, Incidence. \xc3\x98 Review and approval of APQR. \xc3\x98 Review and approval of Method of analysis, Specification, Stability report, Technology transfer and Modification of area. \xc3\x98 Review and approval of hold time study protocol and report. \xc3\x98 Review, approval and Implementation of CAPA. \xc3\x98 To review, assessment and closer of market complaint and product recall. \xc3\x98 Review of pest control and rodent control. \xc3\x98 Training. \xc3\x98 To handle all regulatory, FDA and cGMP audits of customer. \xc3\x98 Review the documents and data control. \xc3\x98 Review and approval of all validation documents. \xc3\x98 To review, monitor IPQA activities. Job Type: Full-time Salary: 9400,000.00 - 9690,000.00 per year Schedule:
Day shift
Ability to commute/relocate:
Vadodara, Gujarat: Reliably commute or planning to relocate before starting work (Required)