IT CSV Specialist
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IT CSV Specialist (GMP/CSV) voor een klant in Limburg, België; hybride 3 dagen/week, 40u, freelance of payroll.
- Locatie
- Limburg, BE
- Werkvorm
- hybride
- Uren
- 40 uur per week
- Contractvorm
- zzp
- Gepubliceerd
Eisen
- HBO-level professionele en intellectuele vaardigheid
- Vloeiend Nederlands en Engels
- Kennis van GAMP 5
- Ervaring met kwaliteitssystemen, procedures, training, etc.
- Kennis van GMP-richtlijnen, farmaceutische richtlijnen, hygiënevereisten, etc.
Wensen
- Master’s of Bachelor’s degree in IT
- Ervaring met het opzetten en beheren van CSV of andere validatiestudies
- Meerdere jaren ervaring in een farmaceutische productieomgeving
Omschrijving
For a customer in Limburg, we are searching for a CSV Specialist to ensure that all IT systems that have an impact on GMP are maintained in a validated state. Responsibilities include maintaining an overview of all IT systems and the extent to which they have undergone CSV; managing and monitoring their validation status to ensure that all software and hardware modifications, changes, and updates are also subject to CSV; keeping the Computerized System Validation Master Plan and all validation-related procedures up to date; maintaining an up-to-date overview of GMP-critical computerized systems and their validation status; preparing specific validation documents for GMP computerized systems, such as risk assessments, regulatory assessments, test protocols, and reports; setting up, implementing, and ensuring the continued effectiveness of validation studies, or coordinating these activities, in consultation with employees from the IT department and potentially also Operations, Supply Chain, Technical Services, QA, and Engineering; documenting, or ensuring the documentation of, all validation activities and validation results, particularly those relating to CSV; contributing to the improvement and optimization of personnel, processes, systems, and implemented procedures; assessing the validation requirements resulting from proposed changes to systems, processes, installations, or equipment, particularly changes relating to CSV; initiating and carrying out the validation of systems, processes, installations, and equipment in a timely manner; ensuring that validation activities are performed to an appropriate standard and comply with applicable international legislation and regulations concerning validation and GMP (GAMP 5 / Annex 11 / Part 11 and data integrity); collaborating across the shared CSV systems, such as ERP, Electronic Batch Record, Asset Management Systems, Artwork Management, and Control Systems; and acting as the Subject Matter Expert (SME) for CSV during external audits. The profile preferably includes a Master's or Bachelor's degree in IT, with at least HBO-level professional and intellectual ability; several years of experience within a pharmaceutical manufacturing environment is an advantage; experience in setting up and managing CSV or other validation studies is an advantage; familiarity with GMP guidelines, pharmaceutical guidelines, hygiene requirements, etc.; knowledge of GAMP 5; and experience with quality systems, procedures, training, etc. Additional details: seniority Medior/Senior, start date October, duration 12 months with extension possible, contract Freelance or Consultant (payroll), location Limburg, onsite policy 3 days per week, hours per week 40, languages Fluent Dutch and English, interview process 1-2 stages.
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