Quality Assurance Manager (OSD Facility)

Role & responsibilities

• Overall responsibility for implementation and compliance of the Quality Management System (QMS).
• Review and approval of quality documents including SMF, VMP, SOPs, BMR/BPR, specifications, validation/qualification documents, calibration and PM schedules.
• Review and approval of complaints, change controls, OOS/OOT, recalls, mock recalls and related regulatory communications.
• Ensure compliance with cGMP/regulatory requirements and approve/reject materials and finished products for release.
• Manage and monitor CAPA, investigations, risk management, data integrity and QMS activities.
• Ensure effective implementation of IPQA, validation, stability, self-inspection and audit programs.
• Review and approve Technical/Quality Agreements and monitor contract manufacturers, suppliers and external laboratories.
• Ensure plant readiness for regulatory, customer and GMP audits and timely closure of observations.
• Drive implementation of regulatory/pharmacopoeial changes and quality requirements for new product introduction/technology transfer.
• Conduct Quality Review Meetings and ensure timely closure of QMS activities.
• Develop Quality strategy and promote a strong quality culture across the organization.
• Lead, develop and manage the QA team, including manpower planning, work allocation, KRAs and performance assessment.
• Ensure adequate manpower, budget and resources for effective functioning of the Quality function.
• Ensure timely escalation and effective communication of critical quality issues to management.

Preferred candidate profile