Specialist IT CSV
Job Location:
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
Major Accountabilities
- Validation Lifecycle Management:Lead and support the full validation lifecycle for GxP and other regulated IT systems including planning execution change control documentation periodic system reviews retrospective system reviews when required and continuous improvement.
- Protocol Development & Risk Assessment: Work with MoonLake system owners to develop and execute validation protocols risk assessments and test plans for systems subject to GxP SOX ISO27001 and related standards.
- Vendor Oversight:Oversee and review vendor validation and computer system assurance activities and due diligence to ensure compliance with internal and external requirements.
- Documentation & Audit Readiness:Maintain comprehensive validation documentation ensuring systems are audit-ready and compliant throughout their lifecycle.
- Periodic and Retrospective Reviews:Coordinate and perform periodic reviews of validated and critical systems to confirm continued compliance intended use data integrity access controls change history incident records and vendor performance. Conduct retrospective system reviews when needed such as after major changes deviations audit findings business process changes or when systems have not been reviewed or validated to the expected standard.
- Audit & Inspection Support:Act as a subject matter expert during audits and regulatory inspections providing validation evidence and guidance.
- Cross-Functional Collaboration:Work closely with IT QA Finance Clinical Operations other departments and vendors to ensure ongoing compliance data integrity business continuity planning disaster recovery and security for all validated systems.
- Training & Guidance:Provide training and guidance on CSV processes documentation and regulatory requirements to relevant stakeholders.
- Bachelors degree in information technology Computer Science Life Sciences or a related field - or proven experience in CSV.
- Minimum 3-5 years of experience in IT Computer System Validation within Biotech or Pharmaceutical is a plus.
- CSV Knowledge.
- Experience with SaaS/cloud-based systems and vendor qualification.
- Familiarity with systems such as Veeva SAP or similar platforms is a plus.
- Understanding of international regulatory frameworks such as EU Annex 11 FDA 21 CFR Part 11 ICH E6(R3) GAMP PICs ISO/IEC 27001 ISO9001. GxP and SOX are a plus.
- Excellent documentation problem-solving and communication skills.
- Ability to work collaboratively in a fast-paced dynamic environment.
- 2 days a week in our brand new Porto office.
MoonLake is a dynamic and innovative company pushing the boundaries of possibility and we are looking for passionate individuals to join our stellar team.
What we offer:
Learning Environment: An opportunity to learn and grow alongside experienced professionals in a supportive and innovative biotech environment.
Impactful Work: Contribute to ground-breaking projects that have the potential to transform global healthcare.
Flexibility and Balance:Work remotely/hybrid enjoying a healthy work-life balance while making meaningful contributions to our team.
Career Growth: A clear path for career progression with the chance to take on more responsibilities as you develop your skills.
MoonLake Immunotherapeuticsis a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab a novel investigational Nanobody for the treatment of the inflammatory disease to revolutionize outcomes for patients.
We continue to make significant progress in our Global Clinical Development Programs. The companys focus is on inflammatory diseases with a major unmet need including hidradenitis suppurativa and psoriatic arthritis conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquarted in Zug with hubs in Cambridge & Porto.
Required Experience:
IC
About Company
MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody® for the treatment of the inflammatory disease, to revolutionize outcomes for patients.We continue to make significant progress in our Glo ... View more
