Executive / Senior Executive - QA Validation

• Plan, execute, and monitor cleaning validation and verification activities for manufacturing equipment and facilities.
• Identify worst-case products and conditions based on risk assessment for validation studies.
• Perform and oversee swab and rinse sampling procedures.
• Conduct Direct Equipment Hold Time (DEHT) and Clean Equipment Hold Time (CEHT) studies.
• Evaluate and qualify cleaning procedures during new product introductions or equipment changes.
  

Documentation & Protocol Management

• Draft, review, issue, and maintain cleaning validation protocols, reports, and related documentation.
• Ensure timely documentation and compliance with current Good Manufacturing Practices (cGMP).
• Maintain a Validation Master Plan (VMP) specific to cleaning validation.
• Manage protocol numbering system for cleaning validation, cross-contamination, and miscellaneous validation studies.
  

Compliance & Audit Support

• Coordinate with internal departments (Production, QA, QC, R&D, Engineering) and external stakeholders (Regulatory, CQA) for validation planning and execution.
• Support internal, external, and regulatory audits by providing required cleaning validation data and documents.
  

Quality System & Continuous Improvement

• Track upcoming cleaning validation requirements for new molecules, products, and equipment.
• Review and update SOPs, validation plans, and strategies to reflect current global standards and regulatory expectations.
• Implement corrective and preventive actions (CAPA) related to cleaning validation activities.
• Close validation-related tasks in systems like Track Wise or other QMS platforms.
  

Training & Technical Support

• Impart training on cleaning validation principles, protocols, sampling techniques, and documentation practices.
• Guide operational and quality teams during execution of cleaning validation activities.
  

Additional Responsibilities

• Communicate effectively with supervisors and relevant stakeholders on the status of cleaning validation activities