Cleaning Validation Subject Matter Expert

About the role

Sun Pharma is seeking a senior professional to lead Cleaning Validation activities across sterile and non‑sterile manufacturing sites. The role combines technical expertise with cross‑functional leadership to ensure cleaning processes meet global regulatory standards.

Key responsibilities

• Lead and manage cleaning validation programs for sterile and non‑sterile facilities.
• Prepare, review, and approve cleaning validation protocols, reports, and master plans (CVMP).
• Act as the site Subject Matter Expert for cleaning validation.
• Establish acceptable limits (MACO/PDE) and conduct risk assessments for cleaning processes.
• Ensure compliance with USFDA, EU GMP, WHO, and MHRA guidelines.
• Drive execution, monitoring, and lifecycle management of cleaning validation programs.
• Collaborate with Quality Assurance, Production, QC, Engineering, and Regulatory teams.
• Support regulatory inspections and audits, addressing observations effectively.
• Investigate cleaning failures, implement CAPA, and manage change control, revalidation, and periodic reviews.
• Optimize cleaning processes for efficiency while maintaining compliance.
• Manage cross‑functional teams and projects, ensuring data integrity (ALCOA+) and proper documentation.

Required profile

• Bachelor’s or Master’s degree in Pharmacy, Chemistry, Chemical Engineering, or a related field.
• Minimum 12 years of total experience, including at least 8 years hands‑on cleaning validation.
• Strong background in Quality Assurance within sterile and non‑sterile pharmaceutical operations.
• Good understanding of production processes and equipment cleaning practices.
• Proven experience handling regulatory audits and inspections.
• Demonstrated ability to lead cross‑functional teams and manage stakeholders.
• Effective communication skills.

Required skills

• Cleaning Validation
• Risk Assessment
• Data Integrity (ALCOA+)
• Regulatory Compliance (USFDA, EU GMP, WHO, MHRA)
• CAPA implementation

What we offer

• Robust benefits and opportunities for personal and professional growth.
• Supportive community that encourages continuous improvement.
• Chance to make a lasting impact in a global pharmaceutical leader.