CSV Specialist

Are you passionate about technology and like to take on complex technical challenges? Do you want to work in exciting projects at renowned clients? At ALTEN we believe that knowing and meeting the expectations of our consultants is a key factor in our success. Our consultants make the difference. Do you want to make the difference too?

 

 

 

Tasks

  • Perform initial & periodical Computerized System validation for all GMP equipment at site 21 CFR Part 11.
  • Ensure the proper execution of the qualification and validation activities.
  • Review and approve risk assessment link to CSV.
  • Co-work with technical Services and other QA departments applied to automated and computerized systems.
  • Support team and management during internal and external audits.
  • Investigate deviations and execute CAPAs

Requirements

  • Degree in automation, engineering, IT, sciences or equivalent by experience.
  • Minimum 1 to 3 years’ experience in a computer systems validation role in the pharmaceutical/agro-food industry.
  • GMP and specific regulations and guidelines applicable to computerized and automated systems (GAMP5, Eudralex Vol 4 annex 11, 21 CFR part 11, …)
  • Good knowledge of English, and French is a big plus.
  • Integrity, positive energy and mind-set, team-player.

We are looking forward to getting to know you and your ambitions!

Détails
Publication date 30/03/2021
Location Neuchâtel
Catégorie Consultants
Recruiter Gemma Izquierdo
Reference Number AD000161