Freelance CSV Specialist - GMP

This position can be filled by freelance or employee consultancy via a payroll partner.

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

• Maintain an overview of all IT systems and the extent to which they have undergone CSV; manage and monitor their validation status to ensure that all software and hardware modifications, changes, and updates are also subject to CSV.
• Keep the Computerized System Validation Master Plan and all validation-related procedures up to date.
• Maintain an up-to-date overview of GMP-critical computerized systems and their validation status.
• Prepare specific validation documents for GMP computerized systems, such as risk assessments, regulatory assessments, test protocols, and reports.
• Set up, implement, and ensure the continued effectiveness of validation studies, or coordinate these activities, in consultation with employees from the IT department and potentially also Operations, Supply Chain, Technical Services, QA, and Engineering.
• Document, or ensure the documentation of, all validation activities and validation results, particularly those relating to CSV.
• Contribute to the improvement and optimization of personnel, processes, systems, and implemented procedures.
• Assess the validation requirements resulting from proposed changes to systems, processes, installations, or equipment, particularly changes relating to CSV.
• Initiate and carry out the validation of systems, processes, installations, and equipment in a timely manner.
• Ensure 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).
• Collaborate across the shared CSV systems, such as ERP, Electronic Batch Record, Asset Management Systems, Artwork Management, and Control Systems.
• Act as the Subject Matter Expert (SME) for CSV during external audits.

Profile

• Preferably 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.
• Familiar with GMP guidelines, pharmaceutical guidelines, hygiene requirements, etc.
• Knowledge of GAMP 5.
• Experience with quality systems, procedures, training, etc.

Additional Details

SENIORITY: Medior/Senior

START DATE: September

DURATION: 6 Months

EXTENSION: Yes

CONTRACT: Freelance or Consultant (payroll)

LOCATION: Limburg

ONSITE POLICY: 3 days per week

HOURS PER WEEK: 40

LANGUAGES: Fluent Dutch/English

INTERVIEW PROCESS: 1-2 stages

If you are interested, please forward your updated resume to [email protected] to be considered.