Senior Quality Process Validation Specialist

Senior Quality Process Validation Specialist provides QA oversight across the three stages of process validation (Process Design, PPQ, CPV) for aseptically filled drug products. Responsible for validating protocols, risk assessments, CPP/CQA identification, validation lifecycle documentation, and ongoing monitoring; reviews and approves life cycle documents, participates in SOP/policy updates, supports deviations and CAPA related to process validation, and stays current with regulatory guidance (FDA/EMA/ICH) and industry best practices. Requires direct experience in PPQ studies, change controls, and interactions with audits/regulatory Inspections; emphasis on regulatory alignment and documentation throughout the process validation lifecycle.