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As 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 Master’s 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.
Our Offer:
- A full-time position with a competitive salary.
- A budget of 16.66% (holiday allowance and year-end bonus) of your gross salary, which can be used monthly.
- Flexible working hours, in consultation.
- Personal training budget of €2,100 every 3 years.
- Contribution to travel expenses from the first kilometer.
- Good accessibility by public transport, with private parking available.
- Pension scheme with Zorg & Welzijn.
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.