Validation Engineer II (GMF106)Apply Now Email Me Job ID SR0037304 Date posted 06/17/2019 Location: Lessines, Belgium
- 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.
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