GxP / CSV Compliance Consultant (Pharma & Biopharma)

Coopers Group AG – Stuttgart
................ For our client in Germany (fully remote within Germany), we are looking for an GxP / CSV Compliance Consultant (Pharma & Biopharma). Your Tasks: * 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 proje