Introduction
We are looking for a QA Validation Officer for one of our pharmaceutical customers. Do you have relevant industrial experience in Validation and QA in a biopharmaceutical industry, knowledge of GMP and knowledge of the different regulations and standards related to validation activities? Then keep reading!
Company/Department
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Function information
We are looking for a QA Validation Officer for one of our pharmaceutical customers. Do you have relevant industrial experience in Validation and QA in a biopharmaceutical industry, knowledge of GMP and knowledge of the different regulations and standards related to validation activities? Then keep reading!
As a QA Validation Officer you have the following tasks:
- Provide QA support and oversight to validation activities according to validation procedures
- Ensure QA oversight in validation activities (IQOQ/PQ/PV/…)
- Review and approve validations documentation regarding the GMP requirements and procedures
- Ensuring that the production practices are aligned with validation conclusion
- Attend project meetings as a QA validation representative
- Ensure timely escalation to Management of critical issues during validation
- Contributing 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 identifying potential quality and compliance risks and managing these risks trough the risk register and quality plan process
- Work autonomously with supervision and coaching
- Defining the validation strategies trough the change control process
- Writing and implementing some validation documentation (Validation Plan, Validation Summary Report, Risk Assessment, Gap Analysis, …)
- Ensuring the correct application of the validation quality systems in the field and to define improvement plan as required
- Supporting the production, QA and technical service teams in the implementation of the validation activities.
Requirements
- University degree in Biotechnology, Agronomy, Chemistry or Pharmacy
- Relevant industrial experience (3-8 years) in Validation and QA in a biopharmaceutical industry
- Knowledge of GMP/CFR/Eudralex/…
- Knowledge of the different regulations and standards related to validation activities
- Fluent communications skills in English and French (written and oral)
- Teamplayer
Offer
Why work as a consultant for Modis Life Sciences? Modis is a part of The Adecco Group, one of the Top 5 companies within the 'Great Place to Work' ranking. At Modis Life Sciences you're not just a consultant, you are one of a kind. Our HR Talent Managers value Talent and build client-focused solutions with that in mind. They are dedicated to help you boost your career.This by coaching sessions, development centers and performance reviews. Respect and professionalism are at the basis of our job. We are willing to go the extra mile for and with you.