GxP / CSV Compliance Consultant (Pharma & Biopharma)

<p>................</p><p>For our client in<strong> Germany (fully remote within Germany)</strong>, we are looking for an <strong>GxP / CSV Compliance Consultant (Pharma &amp; Biopharma).</strong></p><p><strong>Your Tasks:</strong></p><ul><li>Provide expert guidance and support on <strong>GxP compliance</strong> within pharmaceutical and biopharmaceutical environments</li><li>Support the <strong>validation of computerized systems (CSV)</strong> in accordance with applicable regulatory requirements</li><li>Apply and provide guidance on <strong>GAMP 5</strong> principles and relevant validation guidelines</li><li>Contribute to the design and optimization of <strong>change control processes</strong></li><li>Assess planned system changes regarding their impact on compliance and validation requirements</li><li>Evaluate <strong>make-or-buy decisions</strong> from a regulatory and compliance perspective</li><li>Review existing concepts and proposed solutions to ensure alignment with GxP requirements</li><li>Collaborate closely with the project team to ensure regulatory compliance throughout project activities</li><li>Support the development of appropriate compliance and validation approaches for computerized systems</li></ul><p>&nbsp;</p><p><strong>Your Profile:</strong></p><ul><li>Several years of experience in a regulated <strong>pharmaceutical or biopharmaceutical environment</strong></li><li>Strong knowledge of <strong>GxP</strong> and applicable regulatory requirements</li><li>Hands-on experience in <strong>Computerized System Validation (CSV)</strong></li><li>Very good understanding of the <strong>GAMP 5 framework</strong> and its application to computerized systems</li><li>Experience in advising on and designing <strong>change control processes</strong></li><li>Ability to evaluate technical solutions and <strong>make-or-buy decisions</strong> from a compliance perspective</li><li>Good understanding of computerized systems and their regulatory requirements</li><li>Strong analytical and conceptual thinking skills</li><li>Independent, structured, and solution-oriented approach to work</li><li>Excellent communication and consulting skills</li><li><strong>Very good English skills</strong> are mandatory, German language skills are an advantage</li></ul>