Csv Expert

About the Role:

- SAP ERP Systems
- GMP Lab Systems
- Patient Applications (CRM, Website, Support Programs, etc.)

Your role will involve leading the validation strategy for computerized systems in these areas while ensuring continuous compliance across the IT departments. You will also be responsible for defining and reviewing IT processes within your scope to align with our policies and procedures.

Key Responsibilities:

- Project Management: Lead and manage validation projects, overseeing budget, planning, and resource allocation.
- Compliance Standards: Establish, communicate, and enforce rules, compliance standards, and guidelines to ensure sustainable quality and compliance across the managed scope.
- Audit Readiness: Ensure systems are prepared for audits, and take a lead role in presenting and defending these systems during internal or external audits/inspections.
- Non-Compliance Resolution: Address non-compliance issues, ensuring cases are documented, investigated, and resolved or mitigated (e.g., through CAPA management, training compliance).
- Regulated Activities: Maintain the roadmap for sustainable IT compliance, ensuring all regulated activities are managed effectively.

Required Skills and Experience:

- CSV Experience: Over 5 years of experience in Computer Systems Validation (CSV) within regulated environments, with a strong understanding of GAMP5.
- Regulatory Knowledge: In-depth knowledge of GMP, GCP, and GPvP regulations, especially regarding the validation of computerized systems, electronic records/signatures (21 CFR Part 11 and Annex 11), data integrity, and pharmaceutical standards.
- Life Sciences Expertise: Experience in the Life Sciences sector (Pharmaceutical, Medical Devices, Healthcare), with an understanding of system development lifecycle (SDLC) processes.
- Technical Skills: Proficiency in computerized testing processes and tools (e.g., ALM from Micro Focus/Open Text), and supporting processes (Change, Incident, Deviation, Periodic Review).
- Audit Experience: Proven experience in dealing with regulators and auditors, including preparation for and defense during inspections.
- ERP and SAP Knowledge: Understanding of ERP and SAP systems, with particular knowledge of GxP SAP functional domains (PP-PI, WM, QM, PM), SAP authorization, and SAP Basis architecture.
- Language Proficiency: Fluent in English (spoken and written).

**Job Type**: Freelance

Schedule:

- Monday to Friday

Work Location: In person