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Leiden (NL) | 40 hrs.
An exciting Validation Lead position is now available in our close knit Validation Team
In the role of Validation Lead - Qualification and Validation , you will play a vital part in ensuring compliance with regulatory standards and industry practices throughout the qualification and validation processes. Working closely with different teams within the company, you will maintain high-quality and dependable manufacturing operations.
In this challenging position, you can create an impact on our validation strategy in a culture that is characterized by an entrepreneurial spirit. If you look forward to playing a role in helping people live happier and healthier lives, apply below and we look forward to meeting you
Your tasks Develop and execute qualification and validation strategies following regulatory guidelines, which include IQ/OQ/PQ protocols and reports. Work closely with engineering, manufacturing, and quality teams to uphold compliance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDocP). Create validation master plans, protocols, reports, and standard operating procedures (SOPs) to ensure precision and thoroughness. Perform risk assessments and offer advice on minimizing risks associated with qualification and validation tasks. Investigate deviations and non-conformances, and implement corrective and preventive actions (CAPAs) to tackle underlying issues. Stay informed about industry trends, regulations, and best practices in qualification and validation, and share knowledge within the organization. Engage in both internal and external audits and inspections. Maintain oversight of the VMP, monitor adherence trends, and ensure compliance with guidelines. You have HBO or Bachelor's degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or a related field. Demonstrated track record as a validation specialist, particularly in qualification and validation within the pharmaceutical sector. Profound comprehension of GMP regulations and industry standards. Knowledge of qualification and validation procedures for equipment, facilities, utilities, computer systems, manufacturing processes, and analytical methods. Proficient in quality systems, documentation practices, and risk assessment methods. Skilled in deviation and CAPA management, root cause analysis, and change control processes. Meticulous attention to detail, analytical reasoning, and problem-solving abilities. Strong communication and interpersonal skills for effective collaboration with diverse teams. Good command of the Dutch and English language, both verbally and in writing.