Dieses Jobangebot ist archiviert und steht nicht mehr zur Verfügung.
Vakante Jobangebote finden Sie unter Projekte.

QA/Validation Process Engineer

Eingestellt von Harvey Nash IT Recruitment Belgium

Gesuchte Skills: Support, Engineer, Engineering

Projektbeschreibung

QA/Validation Process Engineer

Description:

Perform qualification/validation activities linked to different production phases (Bulk, Finishing or Packing).

Function:

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:

. Define and implement all validation activities related to the project,
. Develop the Validation Plans: define validation methodology and approach. Submit to the Validation Lead for review,
. Provide validation expertise for the development of the project,
. Participate in the risk assessment related to the project,
. Participate in URS, FS and DS definition and writing,
. 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,
. 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 ensure that these are well documented and that corrective actions are taken and followed-up upon,

Education:

Master degree in Engineering or Science or equivalent with experience.

Languages:

French and English.

Projektdetails

  • Einsatzort:

    Hainaut, Belgien

  • Projektbeginn:

    asap

  • Projektdauer:

    6 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Harvey Nash IT Recruitment Belgium