CSV DATA INTEGRITY SPECIALIST – VIE CONTRACT HF

Description de l'offre

Entreprise:
Altran ranks as the undisputed global leader in Engineering and R&D services (ER&D), following its acquisition of Aricent. The company offers clients an unmatched value proposition to address their transformation and innovation needs. Altran works alongside its clients, from initial concept through industrialization, to invent the products and services of tomorrow. For over 30 years, the company has provided expertise in aerospace, automotive, defense, energy, finance, life sciences, railway and telecommunications. The Aricent acquisition extends this leadership to semiconductors, digital experience and design innovation. Combined, Altran and Aricent generated revenues of €2.9 billion in 2017, with some 45,000 employees in more than 30 countries.
www.altran.com e www.altran.com/it
Poste et missions:
Altran Italia is looking for a CSV Data Integrity Specialist to be involved in Energy, Industry & Life Sciences, Rome site.
Main activites and tasks:
- Validation of computerized systems in Life Science field (ERP, LIMS, MES, PLC, SCADA systems) according to the GxP and GMP Best Practice;
- Adaptation of Computerized Systems to FDA 21 CFR part 11 standards;
- Writing of user requirements, protocols, test plants and operative procedures;
- Experience in Data Integrity activities.
Profil:
Ideal candidates have a Master’s degree in Computer Science, Biomedical or Chemical Engineering, Chemistry or Biotechnology, have a good knowledge of Italian (C1) and English language and have gained up to 1 year of experience.
Main requirements:
- Knowledge of FDA, CFR, GAMP5, EMA e cGMP;
- Data Integrity in conformity with CFR21 Part 11 e EU GMP Annex11;
- Knowledge of procedures and processes of the Pharma sector.
- Team working;
- Availability to travel.
Other requirements:
- Great communication skills;
- Problem solving.
To apply:
- Before applying, please verify you are eligible for the VIE program.
- Candidates should send their resume to: specifying in the object of the e-mail “CSV Data Integrity Specialist – VIE contract”.
- In order to manage the hiring process correctly, candidates should also upload the resume on our career site: https://www.altran.com/it/it/carriera/invia-la-tua-candidatura/?offerid=25455
Legally protected status will be considered as an asset.