Job Details
Computer System Validation Senior
0068d00000J1H5ZAAV_1714991396
Posted: Liquid error: Collection was modified; enumeration operation may not execute.
- €40000 - €60000 per annum
- Barcelona
- Permanent
Hybrid / Barcelona
Salary negotiable
Our client leader on Pharma with projects in digital transformation, IA, and SGC, is looking for a Senior Computer Systems Validation (CSV).
Responsibilities
- Manage, lead, and/or support CSV projects together with internal employees and consultants as needed:
- Take responsibility for overseeing CSV projects, ensuring timely and successful completion.
- Coordinate project activities, allocate resources, and track progress.
- Collaborate with internal teams and consultants to ensure project objectives are met.
- Manage, lead, and/or support the qualification of software and infrastructure components supporting regulated systems:
- Develop qualification strategies for software and infrastructure components.
- Collaborate with relevant teams to ensure effective qualification processes.
- Provide consultancy regarding CSV compliance within the Group IT and other stakeholders as needed:
- Act as a subject matter expert on CSV compliance and regulations.
- Provide guidance and support to Group IT teams and stakeholders on CSV-related matters.
- Conduct training sessions or workshops to promote awareness and understanding of CSV compliance
Requirements
- Master's or Bachelor's degree in IT, Quality, Engineering, or a related field of study.
- A minimum of 2 years (senior 5) of experience in the field of Computer Systems Validation (CSV) and/or Quality Management
- Successful management of at least two projects (implementations) in a Validation or Quality-related role,(GxP compliance, validation, and quality systems management, GMP Annex 11, 21CFR part 11, Data Integrity Principles, GAMP 5, ...).
- Experience with validation of cloud-based applications and/or infrastructure is a plus.
- Familiarity with computerized systems validation (ERP, eDMS, eQMS, LIMS, Laboratory systems, EBR, MES, SCADAs, …).
To apply or to learn more about this role, please do not hesitate to contact Julia Montersino at j.montersino@montrealassociates.com
Montreal Associates is acting as an Employment Agency in relation to this vacancy.
Montreal Associates is acting as an Employment Agency in relation to this vacancy.
Julia Montersino
Senior Sales Consultant