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 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:

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 Requirement

📌 Cleaning Validation SME (Vadodara)
🏢 Sun Pharmaceutical Industries
📍 Vadodara