Global Lead IT CSV Amsterdam • Prothya Biosolutions

Key Responsibilities:

Develop Validation Strategies

Design comprehensive validation strategies tailored to specific user and system requirements and regulatory guidelines. This includes defining the validation scope, objectives, methodologies, and resources needed for successful validation projects for computerized systems. Collaborate with project and system stakeholders to ensure alignment between business needs while maintaining compliance.

Execute Validation Protocols

Lead the execution of qualification and validation protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). This involves coordinating testing activities, documenting results, and addressing any discrepancies or deviations according to internal CSV procedures.

Risk Assessment

Conduct risk assessments related to computerized systems to assess GMP-criticality in projects and changes. Identify potential compliance gaps or weaknesses in existing controls such as documentation and computerized system management.

Training & Mentorship

Provide training for IT staff on CSV processes and procedures and regulatory requirements such as GAMP, EU Annex 11, and FDA 21 CFR Part 11. Act as a mentor and as a central point of knowledge for IT staff for everything related to system qualification and validation.

Continuous Improvement

Initiate continuous improvement initiatives by regularly reviewing existing validation processes against industry trends and regulatory updates. Propose enhancements aimed at increasing efficiency while ensuring adherence to quality standards across validated systems over time.

Documentation Management

Oversee documentation management practices including protocol development, test scripts creation, deviation reports, and final validation summaries to ensure they meet audit readiness criteria and are stored in the designated digital and physical locations.

Stakeholder Collaboration

Facilitate collaboration among various stakeholders and departments including IT, Automation, Production (DS, DP), Packaging, Quality Assurance, Quality Control, Medical Affairs and Supply Chain Management. Weigh different interests from parties involved and reach mutually agreed decisions on validation strategies, continuous improvement, and risk assessments.

Your profile:

• At least 5 years of experience in the computer system validation field, preferably in the pharmaceutical sector.
• Prior experience in developing and executing validation strategies, system risk classification assessments, validation project plans, test plans, IOQ protocols, and qualification summary reports.
• Working with a GAMP or FDA compliant Document Management System and Quality Management System.
• Experience converting process improvements and developments in external regulations into internal procedures and quality systems.
• Deep understanding of computer system validation standards, policies, regulations, and best practices. 
• Knowledge of pharmaceutical manufacturing processes and associated quality processes.
• Knowledge of relevant regulations that apply to pharmaceutical companies that produce medicine for humans, such as GAMP5, 21 CFR Part 11, and EudraLex Volume 4 Annex 11.
• Conceptual knowledge of computer systems, applications, networks, and other elements that compose IT and IT-OT architecture.
• Broad understanding of how primary and secondary processes are supported by industrial automation and business automation systems.
• Commitment to staying current with industry trends, regulatory updates, and best practices in computer system validation.
• Fluency in written and spoken English; Dutch language skills are a plus.

We offer you a position with the following employment conditions:

• A market-rate salary
• A budget of 16,66% (holiday allowance and year-end bonus) of your gross salary, yours to spend or to save monthly
• A fulltime employment of 40 hours per week (working part-time can be discussed)
• Flexible working hours after deliberation
• Your own place in a close-knit and expert team with an employer that stimulates growth and personal development
• Good accessibility by public transport and we provide private parking;
• Sound pension provision.

Acquisitie wordt niet op prijs gesteld. Prothya aanvaardt geen ongevraagde hulp van bureaus voor deze vacature. Toegestuurde cv's (in welke vorm dan ook) door bemiddelingsbureaus aan enige medewerker van Prothya zonder geldige schriftelijke zoekopdracht, worden gezien als eigendom van Prothya waarvoor op geen enkele wijze een vergoeding verschuldigd is.