Description
One of our clients, a multinational company in the pharmaceutical industry currently requires a QA Validation Coordinator to ensure the QA Oversight of the continuous validation activities for one or several formulation and filling production units.
Start: 1/1/14
Length: 3 months
Location: South of Brussels
Job purpose:
The QA Secondary Validation Coordinator is part of the QA Operationsfor one MPU.
They ensure the QA oversight of the continuous validation activities for one or several vaccine formulation and filling production units.
Main objectives of this function are:
* To take part in the establishment, the implementation, the follow-upand the maintenance of the continuous validation plan (CVP),
* To define the validation strategies through the change control process (RPC),
* To write and implement some validation documentation (VP, VSR, RiskAssessment, Gap Analysis, Periodic Review and decommissioning documents),
* To review and approve specific qualification and validation documentation (URS, DR, IQ, OQ, Equivalence certificate, PQ, PV and requalification documentation),
* To ensure the correct application of the validation quality systemson 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 the adequate management of validation deviation (be QA GMPResponsible) and potentials CAPA (be Compliance Authority).
Job Factor:
The QA Secondary Validation Coordinator objective implies the following commitments:
* To ensure an efficient and compliant CVP implementation
The responsibilities of the QA Secondary Validation Coordinator are among others:
* Challenge, review and approve qualification and validation (URS, DR,IQ, OQ, Equivalence certificate, PQ, PV and requalification documentation) documentation and ensure they are written in accordance with the client's standards and procedures.
* Write some validation (VP,
* VSR, PVMP Periodic Review and decommissioning documents) documentation according to the client's standards and procedures.
* Ensure adequate oversight and follow-up on the validation deviations both in terms of content (root cause and CAPA).
* Support from a compliance point of view the MPU Product & Processteam, Production and QA Operations for validation topics. Build a strong partnership with these key stakeholders.
* Support the validation approach and decision during internal andexternal audits and help to prepare the strategy of defense with MPU Product & Process team, Production and QA Operations.
* Write and review the gap analysis (Periodic Reviews) in accordancewith planned requirements.
Complexity:
The QA Secondary Validation Coordinator must be able to:
* Understand quickly the characteristics and the mechanism of a broadrange 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
* Demonstrate a quality and compliance mindset through the validation activities
The function requires:
* knowledge of good practices in biopharmaceuticals,
* knowledge of different regulations and standards related to validation activities,
* maintain and keep up to date its knowledge and experience necessary to the function,
* be a good team player in order to succeed in each validation project.
Tags: Validation, Quality Assurance, QA, Production, CAPA