Quality Operations Engineer – CSV

Agap2 is a European engineering and operational consulting group founded in 2005 and specialized in industry. We work in the pharmaceutical, biotechnology, medical devices, watchmaking, and precision mechanics sectors.
As a consultant, you will be required to support our clients in the realization of their projects on-site by providing your expertise and skills. You are agile and eager to adapt to different working environments which will fuel your curiosity to see what lies behind the closed doors of the largest projects in our clients' portfolios.
Quality Operations Engineer – CSV
Your missions
Be a Quality referent for operational teams and support daily activities.
Lead and/or contribute to the management of deviations, CAPA, Change Controls, and investigations.
Take charge of or participate in Computer System Validation activities: strategy, risk analysis, URS, protocols, validation reports, etc.
Guarantee the maintenance of the validated state of GxP computerized systems.
Collaborate with Quality, IT, Engineering, Operations, and Manufacturing teams on cross-functional projects.
Participate in audits, inspections, and inspection readiness activities.
Identify improvement opportunities and contribute to the evolution of Quality Systems.
Profile sought
5 to 10 years of experience in Quality Assurance, Quality Operations, or Quality Engineering in a pharma, biotech, or biopharma environment.
Concrete experience in GMP/GxP and in Computer System Validation (CSV).
Good mastery of Deviation, CAPA, Change Control, and Risk Management processes.
Master's degree or equivalent in sciences, engineering, pharmacy, biotechnology, computer science, or a similar field.
Fluent English. jpidf5d71aajm jpit0835jm jpiy26jm