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CSV Specialist

1 settimana fa

Aprilia, Lazio, Italia Fortil A tempo pieno

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.

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);
  • 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;