Computer System Validation Consultant

1 mese fa

Aprilia, Italia Fortil A tempo pieno

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 2,000 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: Bachelor's or Master's degree in technical-engineering 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

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