GxP / CSV Compliance Consultant (Pharma & Biopharma)

................

For our client in Germany (fully remote within Germany), we are looking for an GxP / CSV Compliance Consultant (Pharma & Biopharma).

• Provide expert guidance and support on GxP compliance within pharmaceutical and biopharmaceutical environments
• Support the validation of computerized systems (CSV) in accordance with applicable regulatory requirements
• Apply and provide guidance on GAMP 5 principles and relevant validation guidelines
• Contribute to the design and optimization of change control processes
• Assess planned system changes regarding their impact on compliance and validation requirements
• Evaluate make-or-buy decisions from a regulatory and compliance perspective
• Review existing concepts and proposed solutions to ensure alignment with GxP requirements
• Collaborate closely with the project team to ensure regulatory compliance throughout project activities
• Support the development of appropriate compliance and validation approaches for computerized systems

• Several years of experience in a regulated pharmaceutical or biopharmaceutical environment
• Strong knowledge of GxP and applicable regulatory requirements
• Hands-on experience in Computerized System Validation (CSV)
• Very good understanding of the GAMP 5 framework and its application to computerized systems
• Experience in advising on and designing change control processes
• Ability to evaluate technical solutions and make-or-buy decisions from a compliance perspective
• Good understanding of computerized systems and their regulatory requirements
• Strong analytical and conceptual thinking skills
• Independent, structured, and solution-oriented approach to work
• Excellent communication and consulting skills
• Very good English skills are mandatory, German language skills are an advantage