The Sr. Validation Specialist performs qualification / validation activities in laboratory and manufacturing areas, including facility and utilities, equipment and computerized systems. He/she prepares and implements the validation documentation required to assure the proper development of a project and manages deviations and changes in order to ensure that these are well documented and that corrective actions are taken and followed-up upon.
Main responsibilities:
- Define and implement all validation activities related to the project - Develop the Validation Plana and methodology and approach - Provide validation expertise for the development of the project (Conduct the risk assessment related to the project; Assure requirements traceability throughout the whole project validation file (to PPQ)) - Organize and coordinate validation activities with the different involved departments; Analyze, interpret, document and report the testing results; - Ensure the follow-up and tracking of the validation activities. - Update the validation documentation system. - Provide support in all quality-related issues, including GMP regulations, compliance with internal SOPs and all aspects of safe, reliable and consistent operation of the system. - Assuring the ability to meet the Department goals in respect to Quality, Finances, Fulfilment and EHS.
- Bachelor of Science or Master of Science in Chemistry or related disciplines - Experiences in chemical operation or validation, in an GMP environment
- Ability to handle multiple tasks and to work towards deadlines
- Fluency in English (written and spoken), German language skills are a plus