QC Specialist

<h3>Company Description</h3><p><strong><em>Eurofins </em></strong>is Testing for Life. Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing, and in discovery pharmacology, forensics, advanced material sciences and agro-science Contract Research services. Eurofins is also a market leader in certain testing and laboratory services for genomics, and in the support of clinical studies, as well as in Biopharma Contract Development and Manufacturing. The Group also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products. With 58,000 staff across a network of 900 laboratories in 54 countries, Eurofins’ companies offer a portfolio of over 200,000 analytical methods. Eurofins Shares are listed on Euronext Paris Stock Exchange.</p><p><strong><em>Eurofins Professional Scientific Services (PSS</em></strong><em>)</em> is a global, award-winning insourcing solution. A Eurofins PSS employs and manages full-time analysts, technicians, scientists, and technical support personnel directly at the client facility to provide long term staffing needs while maintaining the same services, expertise, and cGMP compliance available at the Eurofins facility. Eurofins PSS offers excellent career opportunities for people who have a proven track recording in combining excellent technical ability with first class interpersonal and communication skills.</p><h3>Job Description</h3><p>As a Quality control specialist, you will be:</p><p> Supporting the implementation of New Biological Entity projects from phase III through the life cycle of the product, sharing with the team his high-level scientific expertise and experience. High level the expectations are:</p><ul><li>To provide support to the management team of NBE lab linked to the implementation of the QC   into the new manufacturing site</li><li>To manage protocol, study execution and report for compendial feasibility to support new product introduction within the laboratory</li><li>To support implementation of methods linked to in process samples (i.e. documentation redaction, training of operators,)</li><li>To support product launches (data sharing with authorities, updates of batches, sampling plan, etc)</li><li>To smoothly communicate internally within the Quality Control lab team urgencies and priorities asked by different stakeholders to adjust the planning with the Team lead</li></ul><p> </p><p>Support GMP activities in the laboratory such as</p><ul><li>Change control creation and follow up</li><li>Actions follow up</li><li>Training matrix review and documentation</li><li>Protocol, study execution and report for compendial feasibility</li><li>Update/review of laboratory documentation: analytical methods; analytical instructions; coaching’s modules,…</li><li> Ensure follow-up and compliance of procedures and instructions, and update if needed.</li><li> Ensure follow-up of corrective actions and preventive actions.</li><li> Support product launches and prepare documentation requested by authorities</li><li> Update of batches documentation according to specifications</li><li>Support documentation linked to in process analyses</li></ul><h3>Qualifications</h3><ol><li>Holds master’s degree in analytical chemistry, biochemistry, biology or equivalent.</li><li>Has at least 4 years of work experience with pharmaceutical analysis of, preferably, biological products and more specifically monoclonal antibodies at similar position.</li><li> Experience in GMP.</li><li>Proven experience in documentation creation, update to support QC activity.</li><li>Proven project leadership skills including planning, monitoring, compendial verification with   protocol and reports, decision making and reporting.</li><li>Outstanding communication skills in both French and English is a must. Experience with dealing with different stakeholders / departments is a plus.</li><li> Understanding of all analytical disciplines related to CMC for late stage development and commercial products (analytical development, stability testing and quality control of drug substance, drug product, raw material and intermediate)</li></ol><h3>Additional Information</h3><ul><li>A full-time (40hours/week) Monday – Friday job.</li><li>A Permanent contract with flexible working hours. You can start between 7am - 9:30am.</li><li>Work in a fast growing international organization.</li><li>Meal Vouchers 8 Euro/Working Day.</li><li>Eco-Cheques +/- 250 Euro/Year.</li><li>DKV Hospitalization insurance.</li><li>Additional 12 ADV days.</li><li>A company well-being program targeting both mental and physical well-being.</li><li>A fantastic team with monthly team lunches, fun teambuilding activities (laser tag, escape rooms, sports, etc.) and above all; a great collaborative international work environment</li><li>Personal development through learning on the job and additional trainings.</li></ul>