Quality Management System

- Lead the implementation, maintenance, and continual improvement of the site's Quality Management System.
- Ensure compliance with cGMP requirements, ICH guidelines, WHO GMP, US FDA, EU GMP, MHRA, and local regulatory standards.
- Develop and maintain quality policies, SOPs, procedures, and quality manuals.
- Monitor QMS effectiveness through quality metrics and trend analysis.

Deviation, Investigation & CAPA Management

- Review, approve, and monitor deviations, non-conformances, investigations, and OOS/OOT events.
- Ensure root cause investigations are scientifically sound and completed within timelines.
- Monitor CAPA implementation and effectiveness verification.
- Drive continuous improvement based on investigation outcomes and quality trends.

Change Control Management

- Manage site change control processes for manufacturing processes, equipment, facilities, utilities, computer systems, and quality systems.
- Ensure proper risk assessments and impact evaluations are conducted.
- Monitor timely implementation and closure of approved changes.

Documentation Management

- Oversee document control systems including SOPs, specifications, protocols, reports, master batch records, and quality documents.
- Ensure periodic review and revision of controlled documents.
- Maintain compliance with Data Integrity and ALCOA+ principles.

Audit & Inspection Management

- Plan and coordinate internal quality audits and self-inspections.
- Facilitate customer, corporate, and regulatory audits.




- Lead inspection readiness activities and coordinate responses to observations.
- Track effectiveness of corrective actions arising from audits and inspections.

Quality Risk Management

- Implement Quality Risk Management (QRM) programs in accordance with ICH Q9.
- Facilitate risk assessments using FMEA, HACCP, Fishbone Analysis, and other risk tools.
- Ensure risk-based approaches are embedded within manufacturing and quality processes.

Product Quality Review (PQR/APQR)

- Coordinate Annual Product Quality Reviews (APQR/PQR).
- Analyze process capability, product quality trends, deviations, complaints, and stability results.
- Recommend improvements to enhance product and process robustness.

Training & Compliance

- Manage GMP and QMS training programs.
- Ensure employees are qualified and trained on quality systems and regulatory requirements.
- Monitor training compliance and effectiveness.

Quality Metrics & Management Review

- Prepare and present quality performance reports to site leadership.
- Develop and track KPIs for deviations, CAPA, change controls, complaints, audits, and trainings.
- Conduct Management Review meetings and follow-up actions.

Cross-Functional Collaboration

- Partner with Manufacturing, Engineering, Validation, Warehouse, QC, Regulatory Affairs, and Supply Chain teams.
- Support quality culture initiatives and operational excellence programs.

Interested candidates can send resumes to [email protected]

📌 Manufacturing QMS Manager (Guwahati)
🏢 SUN PHARMA
📍 Guwahati