•Act as site Subject Matter Expert (SME) for validation of equipment, sterile packaging, mixing, water systems (PW/WFI, distribution loops), filling systems (aseptic and non-aseptic), cleaning processes (CIP/COP, manual cleaning validation), and injection molding processes.
•Define critical process parameters (CPPs) and critical quality attributes (CQAs) for complex manufacturing processes using risk-based approaches.
•Draft, review, approve and finalize IQ , OQ , PQ protocols and validation reports for medical device production equipment, testing equipment and facility utilities.
•Lead and oversee on-site validation execution, verify test data integrity, accuracy and traceability.
•Draft, review and optimize validation SOPs, validation master plans and related validation database.
•Manage validation deviations, non-conformances and change controls; drive corrective actions and closure.
•Support internal/external audit, customer audit and regulatory inspection with complete validation documentation.
•Conduct technical communication and coordination with engineering, production, R&D and cross-functional teams on validation matters.
•Ensure all validation activities comply with ISO 13485, FDA QSR 21 CFR 820, MDR and local medical device GMP requirements.