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GxP / CSV Compliance Consultant (Pharma & Biopharma) at Coopers iET · web2ua
GxP / CSV Compliance Consultant (Pharma & Biopharma)
Coopers iETGermany only
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- 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 requirementsEvaluate make-or-buy decisions from a regulatory and compliance perspectiveReview existing concepts and proposed solutions to ensure alignment with GxP requirementsCollaborate closely with the project team to ensure regulatory compliance throughout project activitiesSupport the development of appropriate compliance and validation approaches for computerized systemsYour Profile:Several years of experience in a regulated pharmaceutical or biopharmaceutical environmentStrong knowledge of GxP and applicable regulatory requirementsHands-on experience in Computerized System Validation (CSV)Very good understanding of the GAMP 5 framework and its application to computerized systemsExperience in advising on and designing change control processesAbility to evaluate technical solutions and make-or-buy decisions from a compliance perspectiveGood understanding of computerized systems and their regulatory requirementsStrong analytical and conceptual thinking skillsIndependent, structured, and solution-oriented approach to workExcellent communication and consulting skillsVery good English skills are mandatory, German language skills are an advantageOriginally posted on Himalayas