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QA Validation Engineer

Introduction


Interested to start your career as a consultant at XPE Pharma & Science? We are looking for a QA Validation Engineer.


Company/Department


Why work as a consultant for XPE Pharma & Science?

  • XPE is a part of Adecco, one of the Top 5 companies within the 'Great Place to Work' ranking
  • Dynamic colleagues with passion and drive
  • The opportunity to develop yourself, your competences and skills within our organization
  • An interesting salary with extra-legal benefits. We offer meal vouchers, group- and hospitality insurance.

Function information


As a Qa validation Engineer you are a part of the QA Operations for one MPU. You  ensure the QA oversight of the continuous validation activities for one or several vaccine bulk production units.

Your main objectives of this function are:

  • To take part in the establishment, the implementation, the follow-up and the maintenance of the continuous validation plan (CVP),
  • To assess the validation state of equipment’s through writing periodic review report and/or risk assessments
  • To define the validation strategies through the change control process (CC),
  • To write and implement some validation documentation (VP, VSR, Risk Assessment, Gap Analysis),
  • To review and approve specific qualification and validation documentation (IQ, OQ, PQ, PV),
  • To ensure the correct application of the validation quality systems on the field and to define improvement plan as required,
  • To support the production & technical services teams in the implementation of the validation activities,
  • To ensure the adequate management of validation deviation (be QA GMP Responsible) and potentials CAPA (be Compliance Authority).

Your responsibilities are: 

  • To assess the validation state of equipment’s through writing periodic review report and/or risk assessments
  • Challenge, review and approve qualification and validation (IQ, OQ, PQ, PV) documentation and ensure they are written in accordance with the GSK Vaccines standards and procedures.
  • Write some validation (VP, PQ, PV, VSR, PVMP) documentation according to our client Bio standards and procedures.
  • Ensure adequate oversight and follow-up on the validation deviations both in terms of content (root cause and CAPA).
  • Support from a compliance point of view the MPU Product & Process, Production and QA Operations for validation topics. Build a strong partnership with these key stakeholders.
  • Support the validation approach and decision during internal and external inspection and prepare the strategy of defense with MPU Product&Process, Production and QA Operations.
  • Ensure implementation of validation related commitments towards internal and external authorities and organize the follow-up.

You must be able to:

  • Understand quickly the characteristics and the mechanism of a broad range of production equipment and process including their potential impact on product and patient safety.
  • Use a risk based approach for problem solving and prioritization of tasks
  • Blow a quality and compliance mindset through the validation activities
  • Develop and continuous improve expertise linked to the primary validation activities – expert on the field, technical and regulatory watch over, linked with global and corporate expertise functions
  • Be a strong advocate for validation approaches and activities during internal and external audits

Requirements


As a QA Validation Engineer you have a University degree (Biotechnology, Agronomy, Chemistry or Pharmacy) and at least 5 years professional experience in pharmaceutical environment.

You have good interpersonal relationship skills, you are a team player in order to success in each validation project. You have good oral and written communication skills in French & English. You can easily solve problems and you are result oriented



Offer


Working as a consultant for XPE Pharma & Science means that you will be a part of the Adecco group. You will be guided and be followed-up by one of our Talent Managers. While giving the best of yourself at your project you will be able to develop your soft & hard skills as well via our Talent Managers.


Information


You need more information? Call me soon! Asmae El Addad +32 10 80 71 14


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