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Commissioning & Qualification Engineer

CVO-Europe SA

 
Cointrin
bewerten
Bewertung abgegeben
10.04.2024 100% Festanstellung
CVO-Europe SA

Founded in 2013, Efor has positioned itself as the European reference in specialized Life Sciences consulting over the past 10 years.

With more than 2,000 employees spread across 19 offices in France, Belgium, Switzerland, and the USA, we leverage all of our expertise and methods to help our clients secure the market authorization and maintenance of health products in a constantly evolving technical and regulatory environment.

Recognizing the operational excellence of other sectors known for their culture of innovation and industrial performance, we continue to support our activities in "Global Industries" to enrich Life Sciences expertise with these methods and know-how.

Life Sciences Consultancy powered by Global Industries.

Our group differentiates itself by bringing together committed and unique individuals. We are convinced that beyond the skills and experiences of each person, our greatest strength lies in each individual personality of our team members.

Joining EFOR ensures long-term growth in a diverse and supportive environment where our ambitions and values of excellence, commitment, and sharing will enable you to excel and thrive.

www.efor-group.com

Commissioning & Qualification Engineer

The scope of this activity includes Pharmaceutical process equipment and HVAC/Clean Room/Process.

Your main tasks will be (not exhaustive list) to:

  • Ensure that Qualification phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities,

  • Ensure that Qualification Master Plans are up to date and established for all ongoing projects,

  • Plan, coordinate and execute all phases for qualification of GMP manufacturing systems including but not limited to Qualifications Plans, FMEA, IQOQPQ,

  • Prepare, review and approve technical and GMP related documentation (URS, impact/risk assessment, Master Plans, Qualification documentation, etc.),

  • Operational handling of Changes Controls, CAPAs and Non-Conformances related to qualification topics.

PROFILE

  • You have a degree in Life Sciences, engineering or equivalent by experience.

  • You have at least 2 years of experience in Qualificationin the Life Sciences Industry.

  • You are used to work in regulatory environment and have strong knowledge of regulatory standards related to pharmaceutical or biotechnology environment (GMP, GLP, ICH, 21 CFR, etc.).

  • You speak fluently French and English.

  • You have strong communication skills and an analytical thinking.

Kontakt

Corentin VERMOT-DESROCHES

+41 22 346 52 47


Über die Firma
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