Description
Our client, a multinational company in the pharmaceutical industry,requires a QA Validation Consultant with experience in Formulation
Start: 1/7/13
Length: 31/12/13
Location: South of Brussels
FUNCTION DESCRIPTION: QA VALIDATION IN FORMULATION
S/he ensures the QA oversight of continuous validation activities and project validation activities linked to the new formulation building and associated process transfert.
KEY RESPONSIBILITIES
* Validation documentation
o Challenge, review and approve qualification and validation (IQ, OQ,PQ, PV) >documentatibro Write some validation (VP, PQ, PV, VSR, PVMP) documentation
o ensure it follow the client's standards and procedures
o In termes of content, ensure adequate oversight and follow-up on the validation deviations (root cause and CAPA).
* Be a strong advocate for validation approaches and activities during internal and external audits
o Support the validation approach and decision during internal and external inspection
o Support from a compliance point of view MPU Product & Process,Production and QA Operations for validation topics
o Build a strong partnership with key stakeholders: MPU Product & Process, Production and QA Operations
* Prepare the strategy of defense with MPU Product & Process, Production and QA Operations
* Ensure implementation of validation related commitments towards internal and external authorities
* organize the follow-up of the validation process
PREREQUISITES
Education: scientific university degree
Specific skills
* quality and compliance mindset
* 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
* 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
* Keep-updated on validation process (training, knowledge need, etc.)
* good team player in order to success in each validation project.
Knowledge
* Fluent in English
* good practices in bio pharmaceuticals
* regulations and standards related to validation activities
Experience: min. 1 year experience in a pharmaceutical environment