Process Validation Specialist

The Process Validation Specialist role involves planning, executing, and documenting validation activities for manufacturing processes to ensure compliance with regulatory and quality standards. The primary focus is on establishing robust, reproducible processes that meet quality requirements in the production of IVD kits. Responsibilities include developing and implementing validation protocols for manufacturing equipment and procedures, conducting validation studies for consistent performance, ensuring compliance with ISO 13485, GMP, and regulatory requirements, maintaining proper documentation, analyzing validation data for process improvements, collaborating with cross-functional teams to enhance efficiency, and investigating process deviations with corrective and preventive actions. Additionally, training production and quality teams on validation protocols and regulatory best practices is a key aspect of the role. Qualifications for this position include a Master's degree in a life science background, at least 3 years of experience in the IVD or pharmaceutical industry, proficiency in ISO 13485, and strong skills in data analysis and problem-solving. The ideal candidate should possess expertise in process validation, risk assessment, regulatory and quality compliance, as well as demonstrate proficiency in data analysis and problem-solving to effectively carry out the responsibilities of the Process Validation Specialist role.,