Job Summary

Responsible for maintaining and improving the Quality Management System (QMS) in compliance with cGMP, regulatory requirements, and company quality standards. The role involves handling quality documentation, deviation management, CAPA, change control, risk assessment, training compliance, and supporting audits and inspections.

Key Responsibilities

1. QMS Documentation Management

- Maintain and control SOPs, specifications, forms, protocols and reports.
- Ensure timely review, revision, issuance, and archival of controlled documents.

2. Deviation & Incident Management

- Review, investigate, and document deviations, incidents, and non-conformances.
- Perform root cause analysis using quality tools (5 Why, Fishbone, etc.).
- Track closure of deviations within defined timelines.

3. CAPA Management

- Initiate, review, and monitor Corrective and Preventive Actions (CAPA).
- Verify effectiveness of CAPAs and ensure timely implementation.

4. Change Control

- Coordinate change control activities across departments.
- Assess the impact of proposed changes on product quality, validation, and regulatory compliance.
- Ensure effective implementation and closure of change controls.

5. Risk Management





- Participate in quality risk assessments using tools such as FMEA and Risk Matrix.
- Support mitigation plans.

6. Training Compliance

- Maintain training records and training matrices.
- Monitor completion of GMP and SOP training programs.
- Coordinate refresher and current employee training activities.

7. Audit & Inspection Support

- Participate in self-inspections and internal audits.
- Support regulatory, customer, and certification audits.
- Track audit observations and closure of action items.

8. Quality Metrics & Trending

- Prepare monthly QMS KPI reports.
- Analyse trends for deviations, CAPA, complaints, OOS, and change controls.
- Recommend continuous improvement initiatives.

9. Regulatory Compliance

- Ensure compliance with cGMP, WHO, USFDA, MHRA, EU GMP, and applicable regulatory guidelines.
- Support data integrity and quality culture initiatives.

Experience: 5 To 10 Years

Department: Packing(QMS)

Designation: Executive To Assistant Manager

Education: B.Pharma/B.Sc/M.Pharma/M.SC

Note: Interested candidates can share their resume on [email protected]

📌 Urgent Opening For Packing -QMS(OSD) (Ahmedabad)
🏢 Intas
📍 Ahmedabad