Engineering CSV & QMS Manger

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 environment 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 effectiveness monitoring of quality events.

- Review and assess engineering changes for compliance and validation impact.

- Support trend analysis and continuous improvement initiatives related to engineering quality systems.

Data Integrity & Compliance

- Drive implementation and sustainability of Data Integrity requirements across engineering systems.

- Ensure compliance with ALCOA+ principles and regulatory expectations.

- Identify compliance gaps and implement appropriate corrective and preventive actions.

Audits & Inspection Readiness

- Serve as SME during USFDA, MHRA, WHO, TGA, Corporate, and customer audits.

- Support regulatory inspections and provide responses to observations related to CSV, automation systems, and engineering quality systems.

- Maintain audit-ready documentation and validation records at all times.

Project Support

- Support qualification and validation activities for new equipment, facilities, utilities, and automation projects.

- Participate in technology transfer, commissioning, and engineering projects from a compliance perspective.

- Collaborate with cross-functional teams to ensure timely project execution and regulatory compliance.

Training & Team Development

- Conduct awareness programs on CSV, Data Integrity, and Engineering QMS requirements.

- Mentor team members and develop site capability in validation and compliance practices.

Desired Experience

- 10-15 years of experience in pharmaceutical, biotechnology, or regulated manufacturing environments.

- Strong exposure to USFDA, MHRA, and other global regulatory requirements.

- Hands-on experience in Computer System Validation, Automation Systems, SCADA, PLC, BMS, EMS, TrackWise, SAP, LIMS, or other GxP systems.

- Proven experience in handling regulatory audits and managing QMS processes.

Key Skills

- Computer System Validation (CSV)

- GAMP 5 Methodology

- 21 CFR Part 11 Compliance

- Data Integrity (ALCOA+)

- Change Control Management

- Deviations, Investigations & CAPA

- Equipment & Utility Qualification

- Audit & Inspection Management

- Engineering Compliance

- QMS Management

- Regulatory Documentation

Key Competencies

- Compliance Mindset

- Analytical Thinking

- Problem Solving

- Stakeholder Management

- Attention to Detail

- Cross-Functional Collaboration

- Project Management

- Decision Making

- Leadership & Team Development

Success Measures

- Sustained audit and inspection readiness.

- Timely closure of QMS events and validation activities.

- Zero critical observations related to CSV and Data Integrity.

- Effective implementation of computerized systems in compliance with global regulatory requirements.

Travel Estimate

Job Requirements

Educational Qualification

B.E / B. Tech (Electrical, Electronics, Instrumentation, Computer Science, Mechanical, or related discipline)

Experience

12 to 15 years

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).