Glenmark Pharmaceuticals
Website:
glenmarkpharma.com
Job details:
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
Click on Apply to know more.