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QA Validation

06/11/2019
- Waver

Job content

Provide a compliance expertise in validation:

  • Ensure QA oversight in validation activities (IQOQ / PQ / PV…)
  • Review/Approve the validation documentation regarding the GMP requirements and the procedures
  • Ensure that production practice are aligned with validation conclusion
  • Attend all project meetings as QA validation representative
  • Ensure timely escalation to Management of critical issues during validation
  • Contribute to the deviation process providing QA oversight and approving deviation for deviations related to validation activities and/or impact ofmanufacturing deviations to validation activities
  • Pro-actively identify potential quality and compliance risks and manage these risks through the risk register and quality plan process
  • To define the validation strategies through the change control process
  • To write and implement some validation documentation (Validation Plan, Validation, Summary Report, Risk Assessment, Gap Analysis , Periodic review ….)
  • To ensure the correct application of the validation quality systems in the field and to define improvement plan as required
  • To support the production, QA and technical service teams in the implementation of the validation activities.
Profile
  • Former relevant industrial experience (3+ years) related to the requested seniority in Validation and QA in a biopharmaceutical industry.
  • Knowledge of GMP / CFR / Eudralex …
  • Knowledge of different regulations and standards related to validation activites
  • Good interpersonal relationship skills
  • Good oral and written communication skills in French & English
  • Problem solving and achievement oriented
  • To be a good team player in order to succeed in each validation project and routine activities
  • To be able to use a risk-based approach for problem solving and prioritization of tasks
Contact

Aline Vandermeeren +32 16 30 95 09