Prepare and implement the validation documentation required to assure the proper development of a project and support regulatory submissions.
Act as a validation representative for projects, with support of the Site Validation Lead or Validation Supervisor. Define and implement all validation activities related to the project.
Develop the Validation Plans : define validation methodology and approach. submit to the Site Validation Lead or Validation Supervisor for review.
Provide validation expertise for the development of the project. Lead the risk assessment related to the project. Support and review URS, FS and DS definition Prepare and implement FAT, IQ, OQ & PQ protocols.
Assure requirements traceability throughout the whole project validation file (from URS to PQ). Organize and coordinate FAT, IQ, OQ & PQ validation activities with the different involved departments (on the ground, as required) in such a way that all of them concur with the timeframes committed with the project leader.
Analyze, interpret, document and report the testing results. Ensure the follow-up and tracking of the validation activities.
Update the validation documentation system. Assure feedback of status and issues to Site Validation lead or Validation Supervisor.
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.
Manage deviations and changes in order to guarantee that these are well documented and that corrective actions are taken and followed-
up upon. Take part in internal / external audits. Provide the required information to support the preparation of facility & process related files for the various regulatory agencies.
Support the coordination of junior validation engineers and contractors. Notice to Employment / Recruitment Agents : Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-
owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal.
Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-
owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.