IT Quality Systems and CSV Specialist | Pharma (100% Remote)
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Senior
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Skills: Computer System Validation, IT Quality Management, GxP Compliance, GAMP, ITIL
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IT Quality Systems and CSV Specialist | Pharma (100% Remote)
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Full-time
postgraduate degree
Permanent Contract, Restaurant Tickets, Medical Insurance, Public Transport Ticket, Childcare Check, Gym Network Discounts (Wellhub)
Posted 2d ago
~40 hrs/week
Remote in Sant Cugat del Vallès, Catalonia, Spain
Responsibilities
Ensure IT quality and compliance activities are implemented across the global IT function, focusing on computer system validation and regulatory requirements. Oversee IT infrastructure qualification, review SLC deliverables, and coordinate internal and external audits.
Requirements
Requires a Master's degree in computer science, biotechnology, or a related field with several years of experience in GAMP and ITIL. Candidates must have in-depth knowledge of GxP regulatory environments and excellent communication skills in English.
Full job description
Would you like to work in a global, multicultural team as "IT Quality Systems and CSV Specialist" for a committed international pharmaceutical company?
If improving the quality and efficiency of IT systems and processes is in your DNA, we encourage you to sign up for this offer.
TASKS & RESPONSIBILITIES🚀:
Ensure IT Quality & Compliance activities are effectively implemented and monitored across the global IT function.
Support compliance with applicable regulatory requirements and corporate policies within the IT environment.
Provide Quality & Compliance oversight for IT infrastructure qualification and computer system validation activities.
Review and approve key SLC deliverables, including change controls, risk assessments, testing documentation, periodic reviews, and exception management.
Ensure compliance with CSV, electronic records, electronic signatures, and data integrity requirements.
Implement and monitor IT quality processes, including support during self-inspections.
Collaborate with global Quality and Compliance teams to address business quality and compliance needs.
Promote a culture of quality and compliance across the IT organization.
Deliver GxP and non-GxP compliance training and drive awareness among IT personnel.
Monitor adherence to corporate IT policies, procedures, SOPs, and work instructions.
Coordinate and support internal and external IT audits and inspections.
Conduct IT quality assessments and self-inspections, and monitor the effectiveness of CAPA actions.
Provide proactive quality and compliance guidance to support validation and qualification activities.
REQUIREMENTS 🤹:
Fluent in written and spoken English.
Master's degree in computer science, biotechnology or related field.
Several years of experience with quality management systems (e.g. GAMP) and IT standards (e.g. ITIL).
In-depth knowledge of the regulatory environment (e.g. GxP, audits) and information technology.
In-depth knowledge of GxP-relevant IT processes and their support by computerized systems.
Excellent communication skills, analytical thinking and the ability to work in a spirit of partnership.
Ability to build consensus and influence decisions.
SCHEDULE 🕘:
From Monday to Friday: 08 am to 17 pm / 09 am to 18 pm (flexible)
Possibility of 100% Remote work.
BENEFITS🌱:
Salary package based on your profile. We will discuss it on our first call.
Permanent Contract.
Ticket restaurant included if you go to the office.
Flexible Retribution Program (medical insurance, public transport ticket and childcare check).
Discounts on gym network (Wellhub)
Learning & Development.
Our goal is that you are well in every way!
Related keywords
CSVGxPGAMPITILData IntegrityComputer System ValidationPharmaceuticalQuality Management SystemsCAPASOPSLCIT InfrastructureComplianceAuditElectronic RecordsElectronic Signatures
Experts in digital solutions and regulatory and quality consulting services for the Life Sciences sector
Industry
Business Consulting and Services
Company size
201-500 employees
Founded
2003
Headquarters
Barcelona, Barcelona
LinkedIn followers
6,323
We are a company specialized in providing solutions and services related to Information Technology (IT).
Within a framework of commitment and transparency, and through the efficient integration of our knowledge, experience, and ongoing technological advancements, we offer a range of products, services, and solutions designed to help you effectively and personally meet your needs in any project or requirement related to the dynamic world of information technology.
Offices: C/ Rosselló i Porcel, 21 - Edificio Meridian (Planta 8), Barcelona, Barcelona 08016, ES · Av. Ernest Lluch, 32 TecnoCampus Mataró, Torre 3, 2ª Planta, Mataró, Barcelona 08302, ES
Consultoría de Producto y Transformación DigitalConsultoría Regulatory AffairsIVD y Medical DevicesValidación de sistemas informáticos y Consultoría IT QualityDesarrollo e implementación de herramientas ITSMOutsourcing; Servicios y Operaciones ITGestión de InfraestructurasAsesoramientoimplementación y auditoría de ISO 13485ISO 9001
How many Consulting jobs are open in Sant Cugat del Vallès, Spain right now?
There are currently 48 open consulting positions in Sant Cugat del Vallès, Spain listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Consulting roles in Sant Cugat del Vallès, Spain?
Companies currently hiring include OCA GLOBAL, HP, Boehringer Ingelheim, UVE Solutions, Numerator, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Consulting jobs in Sant Cugat del Vallès, Spain?
Yes — 17 of the 48 open consulting positions offer remote or hybrid work (1 remote, 16 hybrid).
How do I apply for Consulting jobs in Sant Cugat del Vallès, Spain?
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