REQUIRED SKILLS & EXPERIENCE:

• Bachelor’s in sciences or in IT
• 5-6 years working experience as CSV in the pharmaceutical industry, including at least 2 recent years in a clinical environment (GCP)
• Extensive experience in a GCP environment
• § Auditing experience in the pharmaceutical industry
• Proven Data Integrity experience
• § Excellent writing skills for scientifically sound technical documents, instructions, validation protocols and reports in English
• § Working knowledge of related regulatory requirements in the life sciences industry (GAMP 5, 21 CFR part 11, …) tasks effectively. nts, ensuring timely completion.
  You want to have an impact within an innovation focused Biotechnology company and have a passion for Quality and Validation, then this is the perfect opportunity to apply

• Drive the compliance excellence with GxP standards and internal quality guidelines
• Lead inspection readiness efforts alongside the validation team to ensure we’re always audit[1]ready.
• Represent Quality during inspections, audit or other enquiries on CSV matters (e.g. due diligence)
• Oversee and evaluate CSV-related vendor documentation, ensuring vendor compliance.
• Create/approve CSV deliverables and/or assist business units in writing CSV documentation (e.g., Validation Plan, FRS, Test Scripts, Validation Report), and ensure proper filing in respective document management system.
• Coordinate Risk Analysis activities and document respective outcome, ensure mitigations are identified and managed
• Review, assess and approve implementation of changes in the area of responsibility (process, validation templates…)
• Adopt a pragmatic, risk-based approach to balance quality with resources effectively.
• Integrate CSV tasks into project planning, ensuring smooth project execution.
• Ensures awareness of users on CSV and data integrity (authoring training documents, and providing training)
• Escalate serious risks and issues to Quality Management and other functions if applicable (e.g. IT, Business)