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QA Validation Consultant

  1. Brussels
  1. Contract
Competitive
24992
  1. Commisions, Qualification and Validation
Date Posted19 Jun 2020
Job Title: QA Validation Specialist

QA Validation Specialist - Global Pharmaceutical Client – 6 Month Contract in Brussels, Belgium

Our client, one of the world’s largest pharmaceutical organisations is responsible for developing and manufacturing medicines, consumer products and vaccines for a wide range of medical disciplines. They have been responsible for the development of several key and revolutionary products and have a presence in the USA, EU and Asia-Pacific.

With continued organisational growth and a considerable amount of investment across the portfolio and capital programme, they are currently seeking the expertise of QA Validation Specialist to join their team on a contract until the end of 2020.

Essential Duties and Responsibilities for this role include, but are not limited to, the following:
  • Ensure QA oversight in validation activities (IQOQ / PQ / PV)
  • Review/Approve the validation documentation regarding the GMP requirements and the internal procedures
  • Ensure that production practices 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
  • 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.
Requirements:
  • University degree (Biotechnology, Agronomy, Chemistry or Pharmacy)
  • Good oral and written communication skills in French & English
  • 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 activities
 
If you are interested in this role, please apply now for more information!




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