QA Validation Engineer

Who we are

At Capgemini Engineering we value excellence, care, responsibility, dynamism, and innovation. We offer a job with variation that leaves plenty of room for initiative and development. Indeed, we are not just offering you a job, we’re inviting you to be part of our community where we will provide you trainings, tools & grounds for professional and personal growth. Each career experience is assorted by an attractive salary package.

If you are a team player, if you recognize yourself in this profile and are not afraid of taking on challenges… Apply today!

Your role

  • You will give quality assurance oversight (IQOQ / PQ / PV…)
  • 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),
  • You will write and approve validation documents (GMP requirements, protocols, reports, 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

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 3 years 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. https://tms.altran.com/jobs.cfm?offerid=23672

Ref:

138261

Posted on:

June 22, 2022

Experience level:

Experienced

Contract type:

Full-time