Commissioning, Qualification and Validation Consultant H/F

  • Assystem Energy & Infrastructure
  • France
  • déc. 12, 2020
Contrat CDI

Description

As a consultant, you will support our client in the validation of their process. As a Qualification & Validation Engineer, your role will be to ensure that the process of qualification is done with the right level of quality and you will follow regulation, such as GMP and customer's expectations. You will be evolving on these responsabilities: Coordination of the activities with the supplier and management of the aspects of the logistic process; Creation of a detailed schedule of qualification activities in collaboration with the project manager; Commissioning and Qualification of equipment (FAT/SAT); Participation in the writing process of draft risk analyses; Implementation of the qualification master plan and deployment of the strategy in concerned system; Deployment of the qualification activities (IQ; OQ; PQ) and collection of all the documentation; Reading and validation of all project deliverables and ensuring the consistency and quality through all the documentation; Suggestion of optimizations based on best practices approach and experiences with procedures You have a Master in Quality, Pharmacy or a related field You have an experience of minimum 5 years in the Biopharmaceutical/Life Sciences industry, in GMP environments You have a good level in French and/or Dutch and in English You are well organized and independent in daily task with a good team spirit  You are an effective communicator with the ability to relate easily with people

Description entité

Depuis 50 ans, nous sommes animés par la conviction que les ingénieurs, par leur audace, leur expertise et leur capacité à faire bouger les lignes sont les architectes du monde de demain. Tous les jours, nos 5 700 collaborateurs innovent au contact de leurs clients. Ils accompagnent les plus grands projets de l'ingénierie mondiale dans les domaines de l'énergie, de la santé, des sciences de la vie et des transports. Groupe international en forte croissance, nous sommes présents dans 14 pays (Europe, Moyen-Orient, Asie, Afrique). Acteur reconnu pour notre expertise en CQV (Commissioning Qualification Validation) et experts des projets à fortes contraintes techniques et réglementaires, nous accompagnons les laboratoires pharmaceutiques et industries de pointe dans leurs investissements et leurs enjeux liés à la sécurité et à la diminution des coûts et des délais de mise sur le marché. Pour nos clients, nous innovons et intégrons des technologies disruptives dans les domaines de l'intégrité des données, la cybersécurité et la maintenance prédictive.

Entité

Assystem Care

Mission

As a consultant, you will support our client in the validation of their process. As a Qualification & Validation Engineer, your role will be to ensure that the process of qualification is done with the right level of quality and you will follow regulation, such as GMP and customer's expectations. You will be evolving on these responsabilities: Coordination of the activities with the supplier and management of the aspects of the logistic process; Creation of a detailed schedule of qualification activities in collaboration with the project manager; Commissioning and Qualification of equipment (FAT/SAT); Participation in the writing process of draft risk analyses; Implementation of the qualification master plan and deployment of the strategy in concerned system; Deployment of the qualification activities (IQ; OQ; PQ) and collection of all the documentation; Reading and validation of all project deliverables and ensuring the consistency and quality through all the documentation; Suggestion of optimizations based on best practices approach and experiences with procedures

Profil

You have a Master in Quality, Pharmacy or a related field You have an experience of minimum 5 years in the Biopharmaceutical/Life Sciences industry, in GMP environments You have a good level in French and/or Dutch and in English You are well organized and independent in daily task with a good team spirit  You are an effective communicator with the ability to relate easily with people

Métier

Expertise Métier

Date de publication

déc. 12, 2020

Secteur

Sciences de la Vie