Key Responsibilities-

- Handle Engineering Deviations, Incidents, CAPA, Change Controls, and Investigations.

- Conduct Root Cause Analysis (RCA) and ensure effective implementation and closure of CAPAs.

- Perform Quality Risk Assessments related to Engineering systems, equipment, and utilities.

- Track Engineering QMS actions and ensure timely closure within defined timelines.

- Maintain Engineering compliance metrics, trend analysis, and Management Review data.

- Preparation, review, revision, and control of Engineering SOPs, Formats, Risk Assessments, Qualification Documents, and related QMS records.

- Ensure compliance with cGMP, Schedule-M, EU GMP, WHO-GMP, Data Integrity, and company procedures.

- Support regulatory inspections, customer audits, and self-inspections.

- Operate and maintain records in Track-Wise, e-DMS, LMS, and other electronic QMS platforms.

- Ensure completion and effectiveness of departmental training programs.

- Provide support in document review & maintenance of HVAC, Water Systems, and Process Equipment.





- Troubleshoot equipment breakdowns and support investigations related to equipment failures.

- Coordinate with Production, Quality Assurance, Validation, and Engineering teams for execution of quality and compliance initiatives.

Desired Candidate Profile-

- Experience in regulated pharmaceutical manufacturing facilities such as USFDA, EU GMP, MHRA, WHO-GMP, etc.

- Sound knowledge of QMS processes and GMP documentation practices.

- Hands-on experience in Deviation, CAPA, Change Control, and Audit Management.

- Strong understanding of GMP requirements related to Engineering, Utilities, and Equipment.

- Valuable analytical, investigation, and communication skills.

- Exposure to regulatory audits will be an added advantage.

Job Requirements :

- 3-8 years of experience in engineering, manufacturing, or a related field.

- Strong understanding of change control procedures and ability to apply them effectively.

- Experience with CAPA development and implementation is required; knowledge of QMS principles preferred.

📌 Engineering-QMS (Paonta Sahib)
🏢 SUN PHARMA
📍 Paonta Sahib