Position: Manager – Quality Assurance Function: Quality Assurance Reports To: Site Quality Head Location: Goa – Unit I Role Overview The Manager – Quality Assurance is responsible for managing and strengthening the Quality Management System (QMS) to ensure compliance with GMP, regulatory, and internal quality standards. This role provides leadership in OOS/OOT investigations, CAPA governance, SOP management, QMS trending, Management Review Meetings, training oversight, and timely release of finished goods while driving continuous quality improvement across operations. Key Responsibilities Lead preparation, review, and presentation of monthly and quarterly Quality Management Review (QMR) reports; coordinate Management Review Meetings and action tracking. Review, approve, and ensure effective implementation of Quality Assurance procedures and Quality System SOPs. Oversee QMS performance including monthly reports, quality reviews, data trending, and management reporting. Ensure verification of temperature data loggers for materials received under controlled conditions. Govern logging, review, investigation, and closure of OOS/OOT, deviations, incidents, including CAPA and Change Control implementation. Review and approve Phase I & Phase II OOS investigations, ensuring root cause analysis, completeness, and CAPA effectiveness. Ensure timely QA release of finished products in alignment with operational and financial objectives. Ensure execution and effectiveness of GMP, SOP, induction, plant, and external training programs. Ensure effective use of QMS and IT systems including SAP, TrackWise, OpenText, MS Office, LMS, and departmental tools. Ensure compliance with EHS systems as per ISO 14001:2015 and ISO 45001:2018. Perform additional responsibilities as assigned by the Department Head. Key Interfaces Internal: Manufacturing, Quality Control, Engineering, Supply Chain/Warehouse, Regulatory Affairs, EHS, HR & Training External: Regulatory Authorities, Auditors, Vendors, Consultants, Training Institutes Education, Skills, Experience & IJP Eligibility Education Bachelor’s or Master’s degree in Pharmacy, Chemistry, Experience 12–16 years of experience in Quality Assurance within a pharmaceutical or regulated manufacturing environment, with strong exposure to QMS governance and leadership responsibilities. Skills & Competencies Strong knowledge of GMP, QMS, OOS/OOT investigations, CAPA, Change Control SOP lifecycle management, audit readiness, and regulatory compliance Data analysis, QMS trending, and management reporting Proficiency in SAP, TrackWise, OpenText, MS Office, and QMS tools Strong leadership, decision‑making, and cross‑functional coordination skills Preferred Certifications GMP / ISO Auditor Certification CAPA & Root Cause Analysis Training EHS / ISO 14001 / ISO 45001 awareness or certification
Job Title
Manager