Global Lead IT CSV | Brussels
GLOBAL LEAD IT CSV
Prothya is a pharmaceutical company making plasma-derived medicinal products. Plasma-derived medicinal products are based on proteins extracted from blood plasma. Patients use our products for therapies for the treatments from a range of diseases.
Our products greatly impact people’s quality of life and meet the highest quality standards. To sustain this, our processes and systems comply with industry regulations and standards like GAMP, EU Annex 11, and FDA 21 CFR Part 11. This means that computerized systems that impact product quality are subject to qualification and validation procedures. To do this, Prothya needs skilled experts in computer system validation (CSV).
As a IT CSV Lead at Prothya, you are leading validation efforts to ensure that all computerized systems are fit for their intended use, perform consistently, and maintain data integrity throughout their lifecycle. You will be collaborating with cross-functional teams to develop validation strategies, execute validation protocols, and provide training on compliance requirements. The role also includes assessing risk associated with system changes and implementing appropriate controls to mitigate any potential impact. By ensuring that systems are validated according to established guidelines, you contribute significantly in maintaining quality assurance and regulatory compliance while supporting operational efficiency.
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.
Work Experience
- 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.
Skills
- 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.
Additional Information
- Psychological stress can occur in case of calamities and by performing work under time pressure.
- Influence on the quality and efficiency of computerized systems.
- Oral and written expression skills are required for various contacts and documentation.
- The position requires sporadic on-site presence in Amsterdam.
Our Company
Prothya Biosolutions makes life-saving plasma medicines and is proud of that! Every day, Prothya colleagues take the extra mile to improve the health of millions of patients worldwide. Are you looking for a position at a flexible and fast-growing company with an exciting history? At Prothya you can count on an attractive, safe and challenging working environment where everyone gets the chance to show the best of themselves. There is also plenty of room to grow, innovate and learn!
We offer
Prothya Biosolutions Belgium is part of an international biopharmaceutical group which offers long-term career perspectives and invests actively in on-the-job training.
In return for your performance, you shall receive a competitive salary, group and health insurance, meal vouchers, and eco-cheques, as well as a Flex Reward Plan. The Flex Reward Plan is a flexible compensation system through which employees can create a budget from their current salary components. Thanks to this plan, they can enjoy, on a voluntary basis and according to their personal choice, a series of benefits that Prothya Biosolutions Belgium offers once a year.
We also offer an attractive holiday system exceeding the legal holidays and homeworking after a successful onboarding (after 3 months).
Furthermore, we value mutual respect and diversity is our strength.
At Prothya, you can count on an attractive, safe and challenging working environment where everyone gets the chance to show the best of themselves. There is also plenty of room to grow, innovate and learn!
Are you moving along? Then apply now!