Computer System Validation Specialist

Trovato in: Talent IT C2 - 3 settimane fa

Vimodrone, Italia Eurofins A tempo pieno

Job Description

Eurofins BioPharma Product Testing  (BPT) is looking for its site in Vimodrone (MI) a Computer System Validation Specialist  that will collaborate with the European CSV Coordinator to assure the GMP compliance requested for all the computerized systems in use in the Eurofins European Biopharma Product Testing . The role will report to the Quality and Compliance Director.

Main tasks:

Support validation activities; Collaborates on the evaluation of the changes to the computerized systems from a regulation and data integrity requirements perspective; Collaborates on the investigation and resolution of compliance issues that may arise (Deviation and CAPA). Verify if a computerized system is designed according to the applicable regulatory and data integrity requirements: review of User Requirements and Software Specifications; Collaborates on the delivering of the Computerized Systems validation documents; Collaborates to ensure that the system is maintained in the validated status along with its lifecycle, and its validation documentation up-to-date. Deal with the process of “periodic review” of the relevant computerized systems. Maintains updated the EUBPT computerized systems “Inventory List”; Collaborates with internal/supplier audit team during audit in GAMP area.

Qualifications

Professional Experience

Experiences in Quality area with knowledge on: Computer systems related quality processes (e.g. Change Control, Deviation, CAPA); Computer System Compliance and Validation Life Cycle; CFR Part 11 and EU GMP Annex 11 principles; experiences in IT areas with knowledge on computerized systems typically used in Pharma Laboratory environments or equivalent working areas.

Professional Knowledge

Computerized system to analytical laboratory (e.g. CDS, LIS, LIMS); GAMP guidance; GMP Regulation for computer system (EU GMP-volume 4 annex 11; CFR21 part 11) and pharma industry (EU GMP volume 4, CFR21 part 210, 211); Data governance and data Integrity principle;

Managerial Skills

Problem solving; Team working/working together; Precision and control; Flexibility: planning and organizing.

Additional Information

Possibility of Smart Working; Flexible schedule; Ticket Restaurant €8/day; Professional development support.

The type of contract will be assessed on the basis of the candidate's profile.

To apply, it is necessary send a detailed Curriculum Vitae, specifying the authorization to process personal data. CVs without these requirements will not be considered.

To learn more about Eurofins, please explore our website  , 

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