Dieses Jobangebot ist archiviert und steht nicht mehr zur Verfügung.
Vakante Jobangebote finden Sie unter Projekte.
Vakante Jobangebote finden Sie unter Projekte.
QA Validation Formulation Specialist
Eingestellt von Harvey Nash IT Recruitment Belgium
Gesuchte Skills: Support, Consultant
Projektbeschreibung
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
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
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
Organisation/Management, Sonstiges