• Locatie: Wavre
• Vacature #24330

QA Validation Senior

The QA Validation is part of the QA Operations for one MPU. The QA Validation ensures the QA oversight of the continuous validation activities for one vaccine bulk production unit.
Mains objectives of this function are:

• To take part in the establishment, the implementation, the follow-up, and the maintenance of the continuous validation plan (CVP)
• To define the validation strategies through the change control process (change control & MO notification) – Remark: No signature as task approver/stakeholders.
• To write and implement some validation documentation (VP, VSR)
• To review and approve specific qualification and validation documentation (IQ, OQ, PQ, Risk Assessment, Periodic validation review – Remark: No signature as final approver for equipment with high criticality.
• To ensure the correct application of the validation quality systems on the field and to define improvement plan as required.
• To support the production & technical services teams in the implementation of the validation activities

Your responsibilities
The QA Primary Validation objective implies the following commitments:

• To ensure an efficient and compliant CVP implementation
• To provide a compliance and business expertise for some specific technical subjects
• The responsibilities of the QA Primary Validation are among others:
• Challenge, review and approve qualification and validation (IQ, OQ, PQ, equivalence certificate, requalification protocol/report) documentation and ensure they are written in accordance with the Vaccines standards and procedures.
• Write some validation (VP, PQ, VSR)
• Review & approve (not as final approver) Periodic Validation Review documentation according to the Bio standards and procedures.
• Ensure timely escalation to Management of critical issues during validation and/or project.
• Pro-actively identify potential quality and compliance risks and be pro-active in escalation.
• Attend all project meetings as QA expert from a compliance point of view the MPU Product & Process, Production and QA Operations for validation topics.

Skills and knowledge requirements
The QA Primary Validation must be able to:

• Quickly understand the characteristics and the mechanism of a broad range of production equipment and process including their potential impact on product and patient safety.
• Use a risk-based approach for problem solving and prioritization of tasks.
• Blow a quality and compliance mindset through the validation activities.