Engineering CSV & QMS Manger

Sun Pharmaceutical Industries, Inc.; India; On-site; INR 1,800,000 - 3,200,000; Full time

Job summary

Sun Pharmaceutical Industries Ltd. in Dadra, India, seeks an experienced Engineering CSV & QMS Manager to lead CSV and engineering quality systems across the site, ensuring compliance with regulatory standards and data integrity.

The role drives validation lifecycle management and audit readiness. Key responsibilities include coordinating with multiple functions, managing deviations and CAPA, and supporting technology transfers and commissioning from a compliance perspective.

Qualifications

• 10-15 years of experience in pharma, biotech, or regulated manufacturing.
• Hands-on CSV, automation, and validation across GxP systems.
• Experience with regulatory audits (USFDA, MHRA, WHO, etc.).

Responsibilities

• Lead CSV and Engineering QMS activities across the site, ensuring regulatory compliance and data integrity.
• Maintain inspection readiness and support business continuity through validation and quality systems.
• Coordinate with cross-functional teams and external vendors during validation projects.

Skills

CSV

QMS

Audits

Regulatory

Data Integrity

Leadership

CAPA

Education

BE/BTech in related discipline

Tools

SCADA

PLC

BMS

EMS

TrackWise

SAP

LIMS

Job description

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Company: Sun Pharmaceutical Industries Ltd

Job Title:

Engineering CSV & QMS Manger

Business Unit:

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
• QMS Management
• Regulatory Documentation
• 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.

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).