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
