Title:  Cleaning Validation SME

Job Title:

Cleaning Validation SME

Business Unit:

Global Quality & Compliance

Job Grade

Senior Manager

Location :

Tandalja, Vadodara

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:

1. Lead and manage Cleaning Validation activities for sterile and non-sterile manufacturing facilities.
2. Prepare, review, and approve cleaning validation protocols, reports, and master plans (CVMP).
3. Act as Subject Matter Expert (SME) for cleaning validation across the site.
4. Establish acceptable limits (MACO/PDE) and perform risk assessments for cleaning processes.
5. Ensure compliance with global regulatory guidelines (USFDA, EU GMP, WHO, MHRA).
6. Drive execution, monitoring, and lifecycle management of cleaning validation programs.
7. Collaborate with Quality Assurance, Production, QC, Engineering, and Regulatory teams.
8. Participate in and support regulatory inspections and audits, addressing observations effectively.
9. Investigate cleaning failures/deviations and implement CAPA.
10. Ensure alignment of cleaning validation with production operations and campaign management.
11. Optimize cleaning processes to improve efficiency without compromising compliance.
12. Manage change control, revalidation, and periodic review activities.
13. Manage cross-functional teams and projects.
14. Ensure strong adherence to data integrity (ALCOA+) and documentation practices.

Travel Estimate

Minimal to moderate travel (as per project, audit, or site requirements)

Job Requirements

Educational Qualification

Bachelor’s / Master’s Degree in Pharmacy, Chemistry, Chemical Engineering, or related field

Experience

Tenure:  

Minimum 12 years

1. Minimum 8+ years of hands-on experience in Cleaning Validation activities
2. Strong background in Quality Assurance
3. Mandatory experience in sterile and non-sterile pharmaceutical operations
4. Good understanding of production processes and equipment cleaning practices
5. Proven experience in handling regulatory audits/inspections
6. Demonstrated ability to manage cross-functional teams and stakeholder
7. Good in communication

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).