[Hiring] GxP / CSV Compliance Consultant @Coopers Group AG

Role Description

For our client in Germany (fully remote within Germany), we are looking for a 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.

Qualifications

• 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.

Company Description

Die Coopers Group AG ist eine agile Schweizer Recruiting Agentur, die Spezialisten und Führungskräfte in den Bereichen IT, Life Sciences, Engineering und Finance vermittelt. Mit flexiblen Ansätzen bringen wir Kandidat:innen und Unternehmen zusammen, die nicht nur fachlich, sondern auch menschlich zusammenpassen.