Copy of CSV Consultant (Lombardia)
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Job Location:
Monthly Salary:
Posted on:
13 hours ago
Vacancies:
1 Vacancy
Job Summary
Fortil is an international engineering and technology consulting group built on an independent model bringing together over 2500 employees. With 30 offices across 14 countries Fortil fosters entrepreneurial freedom and the empowerment of individual potential.
We are looking for a CSV Consultant for a strategic project.
Location: Lazio
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 technical-engineering or similar subjects (Chemical Engineering Chemistry Industrial Chemistry Mechanical Engineering CTF Pharmacy Biology);
3 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 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;
Why join us
At Fortil we implement concrete initiatives to support your development and ensure an inspiring work environment:
Personalized support to help you grow your skills
An ecosystem that encourages you to step outside your comfort zone
The opportunity to become a shareholder
Involvement in community and non-profit projects
A dedicated policy to support parenthood
Fortil is committed to equal opportunity. All our positions are open to people with disabilities regardless of gender origin or sexual orientation.
Key Skills
- Corporate Paralegal
- Apple
- FMCG Sales
- Academics
- Anesthesia
- Dynamics
