Talent.com
L'offerta di lavoro non è disponibile nel tuo Paese.
Computer System Validation Consultant

Computer System Validation Consultant

FortilAprilia, Italy
Più di 30 giorni fa
Descrizione dell’offerta di lavoro

Fortil is an engineering company founded in 2009. We support our partners in the success of their technical projects in various fields such as Industry IT or Healthcare .

Today we are more than 2000 employees spread over 11 countries . Working with us means working in an ambitious team within a multicultural and international context!

Our ambition is to contribute to building a more responsible communal and inclusive world for our employees and clients.

We are currently looking for a Computer System Validation Consultant.

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 :

  • Bachelors or Masters degree in technicalengineering or similar subjects (Chemical Engineering Chemistry Industrial Chemistry Mechanical Engineering CTF Pharmacy Biology);
  • At least 1 / 2 years of experience on CSV projects in the Life Science field;
  • 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!