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