Job Title:

Engineering CSV & QMS Manger

Business Unit:

Sun Global Operations

Job Grade

G10

Location:

Dadra

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an setting where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

Key responsibilities:

To lead Computer System Validation (CSV) and Engineering Quality Management Systems (QMS) activities across the site, ensuring compliance with regulatory requirements, data integrity standards, and lifecycle management of GxP computerized systems. The role is responsible for maintaining inspection readiness and supporting business continuity through robust validation and quality systems.





Computer System Validation (CSV)

• Lead validation activities for GxP computerized systems, including equipment, automation systems, laboratory instruments, utilities, and software applications.

• Ensure compliance with regulatory requirements including 21 CFR Part 11, EU Annex 11, GAMP 5, Data Integrity, and company procedures.

• Prepare, review, and approve CSV documentation including URS, FS, DS, Risk Assessments, IQ, OQ, PQ, Traceability Matrix, and Validation Reports.

• Manage validation lifecycle activities including implementation, upgrades, migrations, retirement, and periodic reviews.

• Coordinate with Engineering, Quality Assurance, IT, Manufacturing, and external vendors during validation projects.

Quality Management Systems (QMS)

• Manage engineering-related quality systems including Deviations, CAPA, Change Controls, Risk Assessments, Investigations, and SOP management.

• Ensure timely closure and e

📌 Engineering CSV (Dadra)
🏢 Sun Pharmaceutical Industries
📍 Dadra