Responsible for planning, execution, review, and compliance of cleaning validation activities for injectable manufacturing facilities in accordance with GMP and regulatory requirements.
Key Responsibilities
- Prepare and review Cleaning Validation protocols, reports, SOPs, and risk assessments.
- Coordinate and monitor cleaning validation activities for manufacturing equipment, product-contact parts, and production areas.
- Review sampling plans, swab/rinse sampling, analytical results, and acceptance criteria.
- Ensure compliance with GMP, SOPs, validation procedures, and regulatory requirements.
- Manage cleaning validation deviations, investigations, CAPA, and change controls.
- Coordinate with Production, QC, Engineering, and Validation teams for execution of validation activities.
- Support regulatory/customer audits and ensure timely closure of observations.
- Maintain cleaning validation documentation and periodic review/revalidation requirements.
- Identify opportunities for improving cleaning processes and validation practices.
Qualification
B.Pharm / M.Pharm / B.Sc / M.Sc or relevant qualification.