Description
One of our clients, a multinational company in the pharmaceutical industry currently requires a QA Validation Consultant
Start: ASAP
Length: min 6 months + extension
Location: South of Brussels
QA Validation Consultant
KEY RESPONSIBILITIES
Job purpose:
The QA Primary Validation Consultant is part of the QA Operations for one MPU.
He/She ensures the QA oversight of the continuous validation activities for one or several vaccine bulk production units.
Mains 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, Risk Assessment, Gap Analysis),
- To review and approve specific qualification and validation documentation (IQ, OQ, PQ, PV),
- 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 implemetion of the validation activities,
- To ensure the adequate management of validation deviation (be QA GMP Responsible) and potentials CAPA (be Compliance Authority).
Job Factor:
The QA Primary Validation Consultant 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 Consultant are amongothers:
- Challenge, review and approve qualification and validation (IQ, OQ,PQ, PV) documentation and ensure they are written in accordance with the client's standards and procedures.
- Write some validation (VP, PQ, PV, VSR, PVMP) 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&Process, Production and QA Operations for validation topics. Build a strong partnership with these key stakeholders.
PREREQUISITES
The QA Primary Validation Consultant must be able to:
- Understand quickly the characteristics and the mechanism of a broadrange of production equipment and process including their potentialimpact 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
- Develop and continuous improve expertises linked to the primary validation activities # expert on the field, technical and regulatory watch over, linked with global and corporate expertise functions
The function requires:
- a knowledge of good practices in biopharmaceuticals,
- a knowledge of different regulations and standards related to validation activities,
- to maintain and keep up to date its knowledge and experience necessary to the function,
- to be a good team player in order to success in each validation project.
Tags: QA, Validation, GMP, CAPA, Primary, Production, Deviations, pharmaceutical