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QA & Validation Consultant

For one of our clients, a pharma company located in the Walloon Brabant, we are looking for an experienced QA & Validation Consultant.

Job Description

As QA & Validation Consultant, you provide QA support and oversight to validation activities according to our client's validation procedures.

Responsibilities

Provide a compliance expertise in validation:

  • Ensure QA oversight in validation activities (IQOQ / PQ / PV…)
  • Review/Approve the validation documentation regarding the GMP requirements and our client's procedures
  • Ensure that production practice 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

Work in autonomy with our client's supervision/coaching:

  • 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, Pharmacy or related).
  • Existing experience in QA & Validation within a biopharmaceutical industry.
  • Knowledge of GMP/CFR/Eudralex.
  • Knowledge of different regulations and standards related to validation activities.
  • ICT Skills (software, operating systems, hardware, etc.)
  • Fluent in English and in French
  • Problem solving and achievement oriented
  • To be able to use a risk-based approach for problem solving and prioritization of tasks
  • Good team player in order to succeed in each validation project and routine activities

Benefits

  • A balanced salary package based on your skills and experience
  • Hybrid working opportunity
  • Permanent contract