Senior CSV Consultant

FORTIL

  • Aprilia, Latina
  • Tempo indeterminato
  • Full time
  • 2 mesi fa
Fortil is an engineering consulting group active across Europe since 2009. We support our partners in the success of their technical projects in various sectors such as Industry, IT, and Care.Today, we are more than 2,700 employees across 11 countries. Working with us means being part of an ambitious team in a multicultural and international environment!Our ambition is to help build a more responsible, supportive and inclusive world for our employees and clients.We are currently seeking a Senior Computer System Validation (CSV) Consultant to join our growing team in Campania.Responsibilities
  • Validation of computerized systems in the Life Science sector (e.g. laboratory instrumentation control systems, automation systems and quality systems - ERP, LIMS, DMS - according to the GxP reference regulations and GAMP Guidelines;
  • Support in the management of remediation or requalification projects for the adaptation of computerized systems to the FDA 21 CFR part 11/EU Annex 11 regulations and to the Data Integrity regulations and guidelines;
  • Periodic review of computerized systems and user audit trails;
  • Drafting of validation documents: Validation Plans, URS, Traceability Matrices;
  • Drafting and execution in the field of test protocols: IQ/OQ/PQ;
  • Drafting of Risk Assessments;
  • Drafting of computerized system administration procedures;
About You
  • Bachelor's or Master's degree in technical-engineering or similar subjects (Chemical Engineering, Chemistry, Industrial Chemistry, Mechanical Engineering, CTF, Pharmacy, Biology);
  • 5+ years of experience on CSV projects in the Life Science field;
  • Skilled in mapping data flows and performing gap analyses to identify compliance and process improvement opportunities
  • Good knowledge of the reference regulations and guidelines. In particular, knowledge of GMP, CFR 21 Part 11 Regulations, EU/GMP Annex 11, ISPE GAMP5; guidelines, data integrity regulations and guidelines (e.g. MHRA, WHO, EMA, FDA) and ICH guidelines, in particular ICHQ9, is required;
  • Good knowledge of the English language, both written and spoken;
  • Excellent knowledge of the Office package;
Next Steps
  • Someone from the Talent Acquisition department will contact you to schedule an initial HR interview.
  • If successful, a second interview will be conducted to validate your technical knowledge.
  • In case of a positive outcome from the technical interview, there will be a last qualification meeting with the Client.
  • If the final outcome is positive, we will discuss our proposal with you. Alternatively, if the outcome is negative, we will share our sincere feedback!
Why Fortil?Although we currently find ourselves in a significant phase of expansion, the high standards of our projects and recruitments remain as demanding as ever. Quality will always take precedence over quantity, as we prefer excellence to ease!We hope to become the largest independent engineering group in Europe, working to serve future generations. To do so, our operational model is based on four fundamental aspects:
  • Profitable performance
  • Expert engineers
  • Efficient organisation
  • Social responsibility
Apply and join us to become part of a model that is out of the ordinary!

FORTIL