Job description Responsibilities: Lead and support the implementation, maintenance, and continuous improvement of Quality Management Systems (QMS). Review and approve Standard Operating Procedures (SOPs) relevant to the QA department. Develop and implement QA-related SOPs in alignment with regulatory and organizational standards. Oversee the review, approval, issuance, and control of Batch Manufacturing Records (BMRs). Monitor batch quality and ensure BMR compliance. Authorize and release finished batches after thorough quality checks. Conduct and review investigations related to batch deviations, Out of Specification (OOS) results, and other non-conformances. Ensure effective implementation and closure of Corrective and Preventive Actions (CAPA). Review and approve raw material (RM) quality data, including RM vendor audits and approvals. Promote preventive measures to avoid recurrence of deviations, OOS, and related issues. Coordinate and support audits by customers and regulatory agencies, ensuring timely closure of audit observations and full compliance with regulatory requirements. Qualification: M.sc/M.pharm Experience: 5-9 years Please apply & share cv at sakshi.maha@hitechformulations.com
Job description Responsibilities: Lead and support the implementation, maintenance, and continuous improvement of Quality Management Systems (QMS). Review and approve Standard Operating Procedures (SOPs) relevant to the QA department. Develop and implement QA-related SOPs in alignment with regulatory and organizational standards. Oversee the review, approval, issuance, and control of Batch Manufacturing Records (BMRs). Monitor batch quality and ensure BMR compliance. Authorize and release finished batches after thorough quality checks. Conduct and review investigations related to batch deviations, Out of Specification (OOS) results, and other non-conformances. Ensure effective implementation and closure of Corrective and Preventive Actions (CAPA). Review and approve raw material (RM) quality data, including RM vendor audits and approvals. Promote preventive measures to avoid recurrence of deviations, OOS, and related issues. Coordinate and support audits by customers and regulatory agencies, ensuring timely closure of audit observations and full compliance with regulatory requirements. Qualification: M.sc/M.pharm Experience: 5-9 years Location: Baddi Please apply & share cv at sakshi.mahna@hitechformulations.com