Skills:

• Excellent communication (oral and written) and attention to detail.
• 8+ years in Computer System Validation in Life Science domain with minimum 3+ years of experience in managing large global SAP validation projects.
• Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.
• Excellent knowledge of GxP regulations, FDA and EMEA (European Medicines Evaluation Agency ) guidelines including 21 CFR Part 11.
• Excellent knowledge of computer system validation and GAMP -5 standards.
• 15–20 years overall experience, with roughly:
• 8+ years of Computer System Validation (CSV)
• 3+ years managing large/global SAP S/4HANA validation projects
• Pharma / Biotech / Life Sciences / Medical Device / Pharma Manufacturing experience
  
• Strong GxP/GMP/GCP/GLP knowledge
  
• Strong 21 CFR Part 11 knowledge
  
• Strong GAMP 5 knowledge
  
• Hands-on understanding of SAP validation
  
• Strong GxP documentation and validation documentation
  
• Project + change + business stakeholder management.