Requirements: English
Company: Prothya Biosolutions
Region: Brussels Metropolitan Area ,
As Global Lead IT CSV Lead, you will act as the Subject Matter Expert (SME) and process owner for Computerized System Validation (CSV) within the IT/OT/Automation landscape. You will lead and support validation activities, contributing to project execution, compliance, and system quality. Your role will safeguard adherence to GxP, GAMP5, 21 CFR Part 11, and EU Annex 11, continuously enhancing the CSV framework to align with regulatory and technological developments.
Key Responsibilities:
CSV Management and Validation Procedures:
- Develop and maintain CSV policies, procedures, and documentation.
- Manage sub-elements of the Quality System Framework, specifically QSE 4.6 and QSE 6.1.
- Ensure compliance with regulatory requirements and industry best practices.
CSV Expertise:
- Share knowledge and provide training on CSV methods, processes, and systems.
- Serve as a point of contact for customers and during inspections and audits.
- Establish and manage CSV methods, processes, and systems.
- Stay current with regulatory updates and industry standards.
CSV Audits:
- Communicate with auditors during computerized system audits.
- Present validation documentation and evidence to auditors.
- Develop and implement corrective actions in response to audit findings.
- Update CSV policies, procedures, and documentation post-audit.
Compliance:
- Conduct assessments of computer systems, software applications, and processes.
- Collaborate with cross-functional teams to create and maintain validation documentation.
- Perform regular reviews and audits to ensure ongoing compliance.
CSV Projects and Changes:
- Design and implement comprehensive test strategies.
- Coordinate validation efforts with various departments.
- Execute and document validation activities (IQ, OQ, PQ).
- Provide technical guidance and support to project teams.
Qualifications:
- Academic Masters degree.
- At least 5 years of experience in IT, automation, or QC computerized systems.
- Strong understanding of computer systems, software applications, and validation processes.
- Knowledge of GAMP5, 21 CFR Part 11, and EudraLex Volume 4 Annex 11.
- Experience in developing and executing validation test plans, test scripts, and test cases.
- Excellent problem-solving, analytical, and risk-assessment skills.
- Experience within a GMP production environment.
- Fluency in written and spoken English; Dutch language skills are a plus.
Skills:
- Critical evaluation and interpretation of data.
- Strong knowledge of pharmaceutical manufacturing processes and quality systems.
- Commitment to staying current with industry trends and regulatory updates.
- Social skills such as tact, listening, service attitude, and persuasiveness.
- Ability to create and review validation documentation.
- Systematic and orderly work approach.
- Integrity and representative appearance.
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.
- Working in Amsterdam on regular base depending of the business needs
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