Develop, execute, and maintain Cleaning Validation protocols, reports, and lifecycle documentation for pharmaceutical manufacturing equipment and process systems.
* Perform cleaning validation studies, including swab, rinse, visual inspection, and recovery sampling, to demonstrate equipment cleanliness and compliance.
* Establish scientifically justified cleaning acceptance limits using HBEL, PDE, ADE, and MACO calculations.
* Conduct risk assessments to identify worst-case products, equipment, cleaning procedures, and sampling locations.
* Support validation of manual cleaning, Clean-in-Place (CIP), and automated cleaning processes for GMP manufacturing equipment.
* Review analytical laboratory results for product residues, cleaning agents, TOC, bioburden, and endotoxins to verify compliance with acceptance criteria.
* Investigate cleaning validation deviations, failed results, and non-conformances, and implement effective CAPA and corrective actions.
* Collaborate with Manufacturing, Quality Assurance, Quality Control, Engineering, and Technical Operations to coordinate validation activities and project timelines.
* Support change controls, equipment modifications, new product introductions, and periodic review activities to maintain the validated state.
* Ensure compliance with FDA cGMP, 21 CFR Parts 210/211, EU GMP, ICH guidelines, and company quality standards throughout validation activities.
* Prepare and review validation documentation, including Validation Plans, Risk Assessments, Protocols, Reports, SOPs, and technical justifications.
* Participate in internal audits, client audits, and regulatory inspections by providing technical support and maintaining inspection-ready validation documentation.
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