QA Validation Specialist
Brabant Wallon – Consultance
Are you interested in the pharmaceutical industry and putting your knowledge of validation to good use?
Our client is actively looking for a QA Validation Specialist to strengthen its activities.
What are your responsibilities?
As QA Validation Specialist, you are in charge to :
- Responsible for the coordination of the validation of small projects Primary industrialization or Secondary (Formulation or Filling) or QC streams related to equipment such as freeze dryer, autoclaves, oven…or CIP, SIP,Mediabulk, Mediafill, Mediaform or utilities or process control/automation equipment.
- Responsible for defining and implementing an adequate validation strategy in compliance with FDA, EMEA and International quality standards.
- Responsible for ensuring and coordinating the support (planning, weekly validation, resources, cost) to RPCs or projects
- Responsible for VMP (Validation Master Plan)
- Review and approve protocols and certificates for IQ/OQ/PQ and check-lists
- Write QSR (Qualification status report)
- Manage deviations and out of specifications: bring expertise and help in investigating and solving issues
- Ensure correct and state of the art Validation approaches for RPC from Design Qualification step to the establishment of the Qualification Summary report (which is final approved by the QA). This accountability involves knowledge of the Validation Life-cycle process as well as in Specific Validation Strategies (i.e.Cleaning Validation, Aseptic Media Simulation…)
- Participate as expert in external authorities inspections
- Responsible for assuring inspection readiness – regarding Validation – by Corporate functions and RA authorities
- Bring expertise and coaching to streams
- Project Management: control/monitor cost and planning. Take corrective actions if necessary.
- Ensure coordination with all key players (local QA, Global QA, C&M, Streams rep,…)
Who are you?
- You are graduated as a Pharmacist’s degree or a Master Science.
- Expertise in validation, knowledge of International standards (CFR and Eudralex), GMP and Regulatory
- Successful experience in people management
- At least 5 years experience in aseptic processing or vaccine production
- You fluently speak French and English.
What can you expect?
A permanent contract is offered for this function with a salary package matching your skills & experience. The opportunity to develop your skills or to evolve within this company is also open.
You’re interested in this job? We kindly invite you to apply !
