QA Validation Consultant

For one of our clients, we are looking for a QA Validation Consultant

  • Do you have a University degree?
  • Do you have at least 2 years of experience in QA Validation within the pharmaceutical industry sector?
  • Are you fluent in French with a good understanding of English?

Then, you might be the candidate we are looking for !

Job Description 

As a QA Validation Consultant for a project in filling, you provide QA support and oversight to validation activities within the Validation & Technical Service team of the company (10 persons). MPU filling and visual inspection.

Responsibilities 
  • You provide a compliance expertise in validation
  • You ensure QA oversight in validation activities (IQOQ / PQ / PV…)
  • You review/approve the validation documentation regarding the GMP requirements and the GSK Vaccines procedures
  • You ensure that production practice are aligned with validation conclusion
  • You attend all project meetings as QA validation representative
  • You ensure timely escalation to Management of critical issues during validation
  • You 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
  • You pro-actively identify potential quality and compliance risks and manage these risks through the risk register and quality plan proces
  • You define the validation strategies through the change control process
  • You write and implement some validation documentation (Validation Plan, Validation Summary Report, Risk Assessment, Gap Analysis , Periodic review ….)
  • You ensure the correct application of the validation quality systems in the field and you define improvement plan as required
  • You support the production, QA and technical service teams in the implementation of the validation activities.
Profile 
  • You have a university degree
  • You have at least 2 years of experience in QA Validation within the biopharmaceutical industry sector
  • You have knowledge of GMP / CFR / Eudralex …
  • You have knowledge of different regulations and standards related to validation activites
  • You have good interpersonal relationship skills
  • You are fluent in French and have a good understanding of English
  • You are problem solving and achievement oriented
  • You are a good team player in order to succeed in each validation project and routine activities
Contact Information 

Amandine Planche
+32 10 68 53 30
amandine.planche@valesta.com

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