Job Description

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 team-oriented spirit, knowing that we Thrive together and support each other's journeys.

Key Responsibilities
- Lead and manage Cleaning Validation activities for sterile and non-sterile manufacturing facilities.
- Prepare, review, and approve cleaning validation protocols, reports, and master plans (CVMP).
- Act as Subject Matter Expert (SME) for cleaning validation across the site.
- Establish acceptable limits (MACO/PDE) and perform risk assessments for cleaning processes.




- Ensure compliance with global regulatory guidelines (USFDA, EU GMP, WHO, MHRA).
- Drive execution, monitoring, and lifecycle management of cleaning validation programs.
- Collaborate with Quality Assurance, Production, QC, Engineering, and Regulatory teams.
- Participate in and support regulatory inspections and audits, addressing observations effectively.
- Investigate cleaning failures/deviations and implement CAPA.
- Ensure alignment of cleaning validation with production operations and campaign management.
- Optimize cleaning processes to improve efficiency without compromising compliance.
- Manage change control, revalidation, and periodic review activities.
- Manage cross-functional teams and projects.
- 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 Q

📌 Cleaning Validation SME (Vadodara)
🏢 SUN PHARMA
📍 Vadodara