Senior Scientist - Louvain-la-Neuve, België - Zoetis

Zoetis

Geverifieerd bedrijf

Louvain-la-Neuve, België

1 week geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

locations- Louvain-la-Neuve- time type- Full time- posted on- Posted Today- job requisition id- JR Zoetis est le leader mondial de la santé animale, voué à accompagner ses clients et leurs entreprises.

S'appuyant sur plus de 70 ans d'expérience en santé animale, Zoetis découvre, développe, fabrique et commercialise des vaccins et des médicaments vétérinaires, complétés par des produits de diagnostic et des tests génétiques, ainsi que par une gamme de services.

Zoetis est au service des vétérinaires, des éleveurs d'animaux de rente et de ceux qui élèvent et prennent soin des animaux de compagnie et de rente, avec la vente de ses produits dans plus de 100 pays.

Zoetis compte environ collègues qui soutiennent nos activités dans les domaines des ventes, de la recherche et du développement, de la fabrication et de diverses fonctions mondiales.

Lorsque vous rejoindrez Zoetis, vous aurez l'opportunité d'apprendre, de développer vos compétences et d'enrichir votre carrière de nombreuses manières :
formation sur le terrain, travail sur des projets ambitieux ou simple apprentissage entre pairs et managers. Nous bâtissons notre prochaine génération de leaders en investissant dans le développement de nos collègues.

Role Description

The CAPEX Project Validation Specialist is responsible for coordinating all Commissioning/Qualification & Validation activities related to the implementation of new equipment/installations/systems, while providing adequate customer service.

This individual will work in close collaboration with other groups as Engineering, Project Management Office, Quality Assurance & Quality Control, Production and Suppliers to lead qualification & Validation.

As an expert in the commissioning/qualification & validation processes, he/she ensures appropriate Risk Based approach to define Qualification/Validation strategy of a wide range of equipment/installations/systems. He/she will also support other activities, related to current operations (e.g. participating in regulatory audit/inspection, defining strategy to maintain Qualification/Validation status of new equipment/installations/systems installed, etc.).
The CAPEX Project Validation Specialist must be a committed team player and collaborator.
Key Responsibilities
Responsible for the coordination of the validation of projects in all GMP areas (GMS and VRMD facilities) on LLN-Zoetis site. Ensure correct and state of the art Validation approaches, be responsible, with the coaching of his N+1 or a colleague, to establish the Validation Plan and be accountable for all GMP decisions taken during the Validation of the Investment project starting with the Design Qualification step and ending with the establishment of the Validation Summary report Responsible for writing, reviewing and approving validation documents (Risk Assessment (QRM), VQS, IQ, OQ & PQ documents,) Responsible for coordination of VQS or IQ, OQ & PQ execution activities. Responsible for the implementation of the validation guidelines and SOP for the equipment/system/installation (Validation lifecyle process, Commissioning & Qualifications, Aseptic Process Validation). Responsible for ensuring, during the design and validation steps, (until the end of validation lots) for the facility project, writing, an independent review and first approval of validation documentation Participation to perform the writing of the facility submission files for the projects Responsible for participating, for validation sections, in external authorities' inspections (EMEA, FDA, WHO ) with the coaching of his N+1. Responsible for the implementation of adequate validation strategy in compliance with FDA, EMEA and International quality standards. Responsible for assuring inspection readiness regarding Validation by Corporate Zoetis functions and RA authorities (FDE, EMEA, Canada) with the coaching of his N+1 Ensure complete handover with Continuous Validation team at the end of Project Validation Within the GMT/Validation group, participate in the development and review of validation strategies in accordance to regulations. Be the Subject Matter Expert (SME) for Commissioning/Qualification & Aseptic process validation (Sterilization, Environmental Monitoring, Aseptic Process Simulation,). Be the point of contact with active participation (review of validation documentation and backup of project manager on the field if needed) in GMT projects teams (New Products, Product Transfers and In-Line support). Participate in technical training/development (coaching) of GMT and Production members involved in redaction and execution of validation protocols.
Qualifications
Education and experience :_
University degree in appropriate discipline (i.e. pharmacy, biology, microbiology, engineering or other scientific discipline). At least 5 years of validation experience in the pharmaceutical/biotechnology industry.
Technical skills and competenc