Site Validation Lead
Are you accurate, open minded and a great problem solver? Will you make a difference to our company and your colleagues around you? If the answer is YES, then we’d like to hear from you. We are looking to recruit a master’s degree in Technology, Engineering or Sciences, who is customer-focused and speaks fluent English and Dutch with great organizational skills. Are you in?
The Validation Lead (VL) is responsible to lead the validation and maintenance of RRP systems during project as well as run and support phase. The VL ensures the strategy of validation is defined and followed. The VL will perform the QA reviews on documentation produced by the validation engineers and SMEs as per the QMS. The VL supports the business partners in all GxP related decisions, including the compliant, safe, reliable and consistent operation of the computerized system and production equipment.
• Define and lead the validation strategy of the RRP Sites at PMH
• Define, document and maintain the risk assessments (for projects and operations changes) of new and existing systems to support risk based validation approach.
• Author of major validation documentation and the site validation plan.
• Perform QA review of documentation to support the validation of the site equipment and systems.
• Perform QA review of data governance documentation which are produced prior the projects to document data flow and conceptual data model supporting risk analysis of the envisaged systems.
• Participate in the development and improvement of QMS procedures and practices for CSV and DI for the area of responsibility.
• Advice project manager and service manager for validation activities and workload to ensure proper planning and workforce mobilization to perform the activities.
• Support non-conformity (NC) and corrective action/preventive action (CAPA) procedures.
Education and professional desired experience
• Master degree in Technology, Engineering or Sciences;
• 5 - 10 years of experience in computerized system activities or validation activities;
• IS and business experience in pharma industry would be an asset
• Strong knowledge on GLP, GCP, GMP, 21 CFR Part11 and GAMP5 would be an asset
• Experience with Product Lifecycle Management (PLM) system
• Knowledge with Enterprise Resource Planning (ERP) system
• Knowledge with Manufacturing Execution System (MES
RISE TO THE CHALLENGE
You will join a dynamic, international and fast-paced work environment in a constantly evolving industry and will interact with different levels of experience and expertise across the Company. We offer a contract with competitive salary commensurate to the professional experience.
Our company offers you a fresh perspective. Here, you will never stop exploring and discovering. We take on-the-job learning to another level, giving you every opportunity to develop your career and reach your full potential. This position will advance your experience with innovative technologies, services, and processes. Backed by a competitive salary and compensation package, you will work in a professional setting with clients and team members from all over the world. * Reduced-Risk Products (“RRPs”) is the term we use to refer to products with the potential to reduce individual risk and population harm in comparison to smoking combustible cigarettes.