Quality Control Engineer H/F

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

Description

As a Quality Control Specialist you are responsible for the successful execution of the assignments that you are responsible for. In your daily work: You actively contribute to the establishment and implementation of lab compliance related CAPAs resulting from audit observations (external and internal) or from adverse events (e.g.deviations); You are managing QC tests to support commercial manufacturing; You are providing support in case of audits (internal and customer ones) and inspections for Health Authorities; You are writing and taking ownership for SOPs related to testing programs, laboratory operations and/or equipment operations; You are performing and reviewing equipment calibration and maintenance; You are managing complex technical and/or production problems, evaluating potential impact on product quality and escalate to management; You are ensuring quality systems (deviation, OOS investigation, CAPA, documentation, training, change control, validation activities, maintenance and calibration activities) are in place and handled; You are communicating quality control information to all relevant organizational departments, outside vendors, or contractors You hold a Master Degree in Sciences (Microbiology, Bio Engineering, Biotechnology etc) You have at least 3 years professional experience in the pharmaceutical/biotech/medical device industry including QC related experience You are familiar with analytical techniques like HPLC, PCR, GC You have an analytical mind and are able to translate complex processes into clear, efficient and compliant procedures You  have a good level of French and/or Dutch and a good knowledge of English You organize your work efficiently and know how to deal with pressure and deadlines

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 Quality Control Specialist you are responsible for the successful execution of the assignments that you are responsible for. In your daily work: You actively contribute to the establishment and implementation of lab compliance related CAPAs resulting from audit observations (external and internal) or from adverse events (e.g.deviations); You are managing QC tests to support commercial manufacturing; You are providing support in case of audits (internal and customer ones) and inspections for Health Authorities; You are writing and taking ownership for SOPs related to testing programs, laboratory operations and/or equipment operations; You are performing and reviewing equipment calibration and maintenance; You are managing complex technical and/or production problems, evaluating potential impact on product quality and escalate to management; You are ensuring quality systems (deviation, OOS investigation, CAPA, documentation, training, change control, validation activities, maintenance and calibration activities) are in place and handled; You are communicating quality control information to all relevant organizational departments, outside vendors, or contractors

Profil

You hold a Master Degree in Sciences (Microbiology, Bio Engineering, Biotechnology etc) You have at least 3 years professional experience in the pharmaceutical/biotech/medical device industry including QC related experience You are familiar with analytical techniques like HPLC, PCR, GC You have an analytical mind and are able to translate complex processes into clear, efficient and compliant procedures You  have a good level of French and/or Dutch and a good knowledge of English You organize your work efficiently and know how to deal with pressure and deadlines

Métier

Expertise Métier

Date de publication

déc. 12, 2020

Secteur

Sciences de la Vie