Job Title

Job Summary:The Process Validation Specialist is responsible for planning, executing, and documenting validation activities for manufacturing processes in compliance with regulatory and quality standards. This role ensures that all processes used in the production of IVD kits are robust, reproducible, and meet quality requirements.Job Responsibilities:Develop and implement process validation protocols (IQ, OQ, PQ) for manufacturing equipment and procedures.Conduct validation studies to ensure processes achieve consistent and reliable performance.Ensure all validation activities comply with ISO 13485, GMP, and regulatory requirements.Maintain proper documentation, including validation master plans, reports, and risk assessments.Analyze process validation data, identify trends, and recommend process improvements.Work with cross-functional teams to enhance efficiency, reduce variability, and optimize production.Investigate process deviations and implement corrective and preventive actions (CAPA).Train production and quality teams on validation protocols, regulatory requirements, and best practices. Qualifications:Master's degree in life science background.3+ years of experience in the IVD or pharmaceutical industry is requiredProficiency in ISO 13485Data Analysis & Problem-Solving Required Skills:Process Validation & Risk AssessmentRegulatory & Quality ComplianceData Analysis & Problem-Solving