VUPICO - CSV Lead - SAP S/4 HANA Platform

Job Type :

About The Role

Key Responsibilities

• Lead and manage CSV (Computer System Validation) activities across the project lifecycle, including concept, implementation, operations, and retirement phases.
• Work closely with teams involved in SAP S/4HANA upgrade initiatives.
• Review and approve validation deliverables to ensure compliance with regulatory guidelines and internal quality standards.
• Ensure adherence to GxP, GAMP5, 21 CFR Parts 11, 210, 211, 820, EU Annex 11, and GDP (ALCOA+).
• Collaborate with stakeholders in both Japanese (JLTP N1) and Business English for effective communication and documentation.
• Drive quality compliance activities including deviations, change controls, CAPA, and other QMS processes.
• Act as a key liaison between technical teams, QA, and regulatory stakeholders.
  

Required Skills & Qualifications

• Minimum 10 years of hands-on experience in CSV, cloud validation, QA, and regulatory compliance.
• Proven track record with SAP S/4HANA implementations or upgrade projects.
• JLTP N1 certified with strong command of Business English.
• Deep understanding of pharmaceutical and life sciences regulatory frameworks.
• Proficiency in QMS tools and documentation standards for validation activities.
• Strong analytical, problem-solving, and communication skills.
• Ability to work independently in a remote, multicultural environment