Che lavoro cerchi?
In quale città?

CSV - Computer System Validation Specialist


  • Tipo: Offerta di lavoro
  • Offerta inserita il: 13.05.2022
  • Offerta scade il: 02.06.2022
  • Posti disponibili: 1
  • Luogo: Ferentino (FR)
  • Categoria Professionale/Mansione: Varie/Altro
  • Settore: Chimico-farmaceutico
  • Offerta pubblicata da: Adecco Consultant
For our important client (pharmaceutical sector) we are looking for a

CSV - Computer System Validation Specialist

You will ensure that the computerized systems are validated and in compliance with the main Italian, European and American regulatory requirements (NBF/EU Annex/ CFR).

Essential Functions
• Ensure the execution of validation activities for CSV projects according to the timeline, procedures and the priorities defined by the company
• Lead cross functional team and external personnel on assigned projects as defined within the Proactive Quality plan
• Draft the main validation documents (URS, plans, risk analysis, test protocols and reports) in accordance with the internal procedures, collaborating with other departments and external consultants
• Ensure that the validation documentation produced or issued by suppliers complies with internal quality standards.
• Ensure the regular planning and implementation of CSV training.
• Provide training for external personnel involved in validation activities.
• Ensure the continuous update of CSV procedures according to the internal, industry and regulatory trend.
• Support the management of external personnel involved in validation activities
• Administrators Audit Trail Review
• Computer System/SAP access periodic review
• Management of any related non-conformity emerged during the Audit Trail/periodic review
• Support on the resolution of any anomalies emerged Computer Systems
• Support on the management of deviations involving Computer Systems.
• Participation during customer and regulatory inspections
• Support for Proactive Quality/Data Integrity initiatives

Technical and soft Skills

• Degree pharma, chemical, engineering on computer science
• Minimum 3 year computer system validation experience
• Pharma/Manufacturing experience
• Knowledge of GMPs, Data Integrity, GAMPs and CFR part 11 regulations
• Strong interpersonal skills with proven ability to build and maintain relationships, teambuilding, adaptability, excellent problem solving & communication skills
• Fluent in Italian and English



Data inizio prevista: 01/07/2022

Categoria Professionale: Ingegneria Impiantistica

Settore: INDUSTRIA CHIMICA/ CHIMICA-FARMACEUTICA

Città: Ferentino (Frosinone)

Istruzione:
  • Laurea Triennale

Conoscenze linguistiche:
    Inglese
  • Parlato: Ottimo
  • Scritto: Ottimo
  • Comprensione: Ottimo

Disponibilità oraria:
  • Full Time


I candidati, nel rispetto del D.lgs. 198/2006, D.lgs 215/2003 e D.lgs 216/2003, sono invitati a leggere l'informativa sulla privacy. (Regolamento UE n. 2016/679).
Facsimile di domanda è disponibile al seguente link Facsimile domanda candidatura.
ATTENZIONE: Abbiamo rilevato la presenza in rete di molti annunci falsi; prendi visione dei nostri consigli per riconoscere i tentativi di truffa al seguente link.
Adecco Italia S.p.A. (Aut. Min. Prot. N.1100-SG del 26.11.2004).
Rispondi all'offerta
Attendere prego...
Operazione in corso