freelance
Quality Validation Technician Medior Reference number: 288
Published: 09-05-2018, 16:53
Sector: Pharmaceutical
Start: 01 May 2018
Job description
Coordinate and support validation activities for product development projects to be implemented at the manufacturing plant.
He / She will be integrated in the project team composed of engineering, quality, manufacturing, R&D, and support department.
He/She will be the representative of the product development team for validation activities and will provide the validation inputs at each phase of the product development project
What you’ll do
  • Project design phase : He / She will act as the reference for quality assurance guidance during the development phase
    • Consolidate the validation and quality requirements
    • Define and coordinate the project documentation preparation and review (URS / FS / DS)
    • Develop risk assessment (process FMEA, etc…) to allow to define the validation strategy and future in-process controls
  • Implementation phase : He/She will lead the validation activities during the implementation phase
    • Plan and coordinate of validation activities in alignment with the project timelines, follow up and reporting
    • Define the validation strategy in collaboration with the Quality Assurance Department
    • Ensure the traceability of activities throughout the whole project validation file (from URS to PQ).
    • Prepare protocols for FAT, IQ, OQ, PQ, process validation, cleaning validation and stability batches productions as required by the product development projects need and as defined within the validation strategy
    • Lead and coordinate the issue resolution in collaboration with the manufacturing, engineering and quality team
    • Analyze, interpret, document and report the testing results.
    • Prepare the reports for FAT, IQ, OQ, PQ, process validation, cleaning validation and stability batches productions as required by the product development projects need and as defined within the validation strategy
Profile
  • Engineer, bachelor with 5 years’ minimum experience in validation, QA
  • Good Communication skills
  • Good problem solving and critical thinking skills
  • Good knowledge of English
  • Versatility, autonomy, rigor and reactivity
  • Good knowledge of current European and FDA regulations
  • Good knowledge in statistical analysis
Required Skills
  • Knowledge of project methodology as there will be some logistics coordination tasks
  • Previous pharmaceutical experience
  • 3 years of experience as a validation engineer
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