Brabant-Walloon - Contracting 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 equipments 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 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 companies Vaccines standards and procedures Write some validation (VP, PQ, VSR) Review & approve (not as final approver) Periodic Validation Review documentation according to the Companies 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. Understand quickly 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 Jefferson Wells offers you a permanent contract as a consultant wi... Prioritize Workload, Expertise, Documentation, Maintenance, IQ, Risk Analysis, Technical service, Risk Compliance, Strategies, Vaccine, Business, CVP, Validation, OQ, Projects, PQ, Quality systems, QA Validation, VOS, Patient Safety, Proactivity, Production, Operations, Change Control, Quality assurance, Problem Management, Implementation Originele vacature is te vinden op StepStone.be – Maak nu een Jobagent aan op StepStone en vind je droombaan! https://bit.ly/2jPYsZC Vind gelijkaardige jobs, informatie over werkgevers en carrièretips op StepStone.be!
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