QA Project Manager

QA Project Manager

Keyrus Life Science

Wavre, Belgium

Job Description

Keyrus Life Science is looking for a senior QA Project Manager to join our consulting team for a client project based in Wavre.

The purpose of the project is to support and give oversight to validation and manufacturing activities according to our client validation and production procedures.

Your challenges will be:

  • Ensure QA oversight in validation activities (IQOQ / PQ / PV…)
  • Review/Approve the validation documentation regarding the GMP requirements and the procedures (vaccines)
  • 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 ….)

Profile

  • Open for a temporary project of 4 months
  • University degree (Biotechnology, Agronomy, Chemistry or Pharmacy)
  • Tools (e.g. SAP, documentum) is an asset
  • 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
  • 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
  • Sense of urgency

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© EuroJobsites 2022

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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