SME Computer System Validation

Title:

SME CSV

Location:

Mumbai/Baroda

Key Responsibilities

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.”

JOB DESCRIPTION

Role Purpose

Provide enterprise ownership for manufacturing CSV practices across the organization, ensuring globally consistent, compliant, and efficient processes in a regulated pharmaceutical environment.

Scope of Responsibility (Enterprise-Level)

• Multi-site, multi-market operations
• GxP and non-GxP processes with clear risk segregation
  
  

Key Responsibilities

Enterprise CSV & Compliance Leadership

• Own the enterprise CSV strategy for all manufacturing equipment in SUN Global Operations (drug formulations)
• Ensure a risk-based, inspection-ready validation model aligned with global regulatory expectations (FDA, EMA, MHRA, WHO, etc.).
• Govern validation standards, templates, and approaches across regions to prevent local over-validation and inconsistency.
• Serve as the primary senior SME during global regulatory inspections, corporate audits, and remediation programs.
  
  

Governance, Change & Release Management

• Ensure system changes support long-term architectural integrity, not short-term fixes.
• Make hard calls on scope, prioritization, and risk—clarity over consensus.
  
  

Transformation & Strategic Programs

• Ensure operational excellence and compliance are designed in, not bolted on later.
• Challenge system integrators and vendors on value, quality, and accountability.
  
  

Capability Building & Culture

• Build enterprise capability in CSV, compliant ways of working.
• Shift the organization from a validation-heavy, improvement-light mindset to one focused on risk, control, and value.
• Mentor senior leaders and SMEs across regions.
  
  

Required Experience

• 15–20+ years’ experience in pharmaceutical or life sciences enterprises.
• Deep expertise in CSV for large, complex systems with global regulatory exposure.
• Track record of driving enterprise-wide standardization and transformation, not isolated improvements.
• Experience engaging with regulators, auditors, and senior executive leadership.
• Strong background working across global, matrixed organizations.
  
  

Skills & Leadership Attributes

• Strong regulatory judgment—knows when to push back and when to escalate.
• Lean / Six Sigma thinking applied at enterprise scale.
• High executive presence; influences without authority.
• Data-driven, decisive, and outcome-focused.
  
  

Travel Estimate

50-60 %

Job Requirements

Educational Qualification

Graduate (Science and Engineering)

Experience

15–20+ years’ experience in pharmaceutical or life sciences enterprises

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).

---