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). 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 project activities - Support the development of appropriate compliance and validation approaches for computerized systems Your Profile: - 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 Originally posted on Himalayas