Ingénieur Validation

Job Description

Assistance to the realization of Commissioning Qualification and validation of clean utilities Required Experience & Knowledge : • Former relevant industrial experience 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 Soft skills: • 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 Tasks : Ensure QA oversight in validation activities (IQOQ / PQ / PV…) • Review/Approve the validation documentation regarding the GMP requirements and the GSK Vaccines 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 of manufacturing deviations to validation activities • Pro-actively identify potential quality and compliance risks and manage these risks through the risk register and quality plan process • Work in autonomy with supervision/coaching • 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.

Job Summary

  • Published on: 02 Mar, 2022
  • Job Location: France