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QA validation Engineer

Capgemini

Capgemini

Quality Assurance
Belgium
Posted on Apr 24, 2024

Your role

  • You will give quality assurance oversight on (IQ/OQ /PQ /PV…) protocols and reports,

  • You will help define and support the Validation Approach,

  • You will establish procedures for Validation in accordance with international standards (FDA, EMA, ICH, ASTM E2500, GAMP, CFR),

  • You will perform risk assessments,

  • You will write and approve validation documents (GMP requirements, SOPs, Critical Impact Assessments, …),

  • You will make sure that production practice are aligned with validation conclusion,

  • You will communicate to management about issues in the validation process,

  • You will attend project meetings,

  • You will provide QA oversight and approve deviation,

  • You will pro-actively identify potential quality and compliance risks by managing these risks through the risk register and quality plan process,

  • You will define validation strategies through the change control process,

  • You will write and implement validation documentation (Validation Plan, Validation Summary Report, Risk Assessment, Gap Analysis , Periodic review, ….),

  • You will ensure the correct application of the validation quality systems in the field and define an improvement plan as required,

  • You will support the production, QA and technical service teams in the implementation of validation activities,

  • You will work in close collaboration with production, engineering, maintenance, QC, QA…

Your profile

  • Master’s degree in (Bio-)engineering, Chemistry, Pharmacy or related scientific domains,

  • French or Dutch fluent and fluent in English,

  • A minimum relevant experience of 1 year in the (bio)pharmaceuticals, medical devices or biotechnology sector,

  • Knowledge of GMP / CFR / Eudralex and the different regulations / standards related to validation activities are a big plus,

  • Good interpersonal relationship skills,

  • Problem solving and achievement oriented,

  • Be a good team player in order to succeed in each validation project,

  • Be able to use a risk-based approach for problem solving and prioritization of tasks.

**#LI-CO2 **