<div class="show-more-less-html__markup show-more-less-html__markup--clamp-after-5 relative overflow-hidden"> <p><strong>Senior QC Analytical Validation Consultant – Freelance / Independent Consultant</strong></p><p><br/></p><p><strong>Company Description</strong></p><p><br/></p><p><strong>GMP Bridge AG</strong> is a senior GMP and Quality consulting firm based in Switzerland, supporting biotech, biopharma, CDMO and advanced therapy organizations across Europe.</p><p>We focus on complex GMP and Quality topics where practical judgement, technical ownership and inspection-ready execution are required, including Quality systems, sterile manufacturing, CDMO oversight, inspection readiness, remediation, validation, CSV/CSA, data integrity and analytical QC support.</p><p><br/></p><p>For one of our biopharma clients in Germany, we are currently looking for a Europe-based Senior QC Analytical Validation Consultant to support a Sample Hold Time Studies work package.</p><p><br/></p><p><strong>Role Description</strong></p><p><br/></p><p>The consultant will support the initial phase of the project, focused on gap analysis and risk assessment across analytical QC methods related to sample hold time studies.</p><p>This is a freelance contract role, mainly remote, with occasional visits to Germany if required.</p><p>The work will involve reviewing existing analytical QC methods, assessing current sample hold time / sample stability approaches, identifying potential GMP and documentation gaps, and supporting risk-based recommendations for the next project steps.</p><p>The consultant will work with the GMP Bridge team and client stakeholders from QC, QA and related functions.</p><p><br/></p><p><strong>Expected Scope</strong></p><p><br/></p><ul><li>Review of analytical QC methods and related documentation</li><li>Assessment of current sample hold time / sample stability rationale</li><li>Gap analysis against GMP expectations and inspection readiness needs</li><li>Risk assessment of current practices across analytical methods</li><li>Preparation of clear, inspection-ready technical documentation</li><li>Support to client discussions and project workshops</li><li>Input into recommendations for further study design or remediation activities, if required</li></ul><p><br/></p><p><strong>Project Setup</strong></p><p><br/></p><ul><li>Start: August 2026</li><li>Estimated effort: approx. 80–120 hours</li><li>Location: Mainly remote</li><li>Contract type: Freelance / independent consultant</li></ul><p><br/></p><p><strong>Qualifications</strong></p><p><br/></p><ul><li>Strong hands-on experience in analytical QC within GMP-regulated biopharma environments</li><li>Experience with analytical method validation, qualification, transfer or life-cycle management</li><li>Practical knowledge of sample hold time studies, sample stability assessments or related QC risk assessments</li><li>Ability to review analytical methods and identify GMP, documentation and inspection-readiness gaps</li><li>Strong technical writing skills and experience preparing clear GMP documentation</li><li>Good understanding of QC laboratory processes, data integrity expectations and regulatory inspection standards</li><li>Experience working independently as a freelance consultant or through own company</li><li>Strong communication skills and ability to work with QC, QA and cross-functional client teams</li><li>Experience in biologics, sterile manufacturing, advanced therapies, CDMO environments or complex analytical QC settings would be highly beneficial.</li></ul><p><br/></p><p><strong>Important</strong></p><p><br/></p><p>We are considering independent consultants only, working as registered freelancers or through their own company.</p><p>GMP Bridge AG works directly with clients and independent consultants only. No agencies or intermediaries, please.</p><p>Consultants must be based in Europe for this opportunity.</p><p><br/></p><p><strong>How to Apply</strong></p><p>Interested consultants can contact us at: contact@gmpbridge.com</p><p>Please include your availability, relevant experience and approximate hourly rate range.</p> </div>