ESO QA Specialist

<p><b>MISSION STATEMENT</b></p><p><span>To ensure the quality lifecycle management for dedicated, subcontracted, product portfolio. Qualified auditor.</span></p><p></p><p><b>MAIN ACCOUNTABILITIES AND DUTIES</b></p><p>Operational skills</p><p>Operational quality management of a dedicated product portfolio which includes:</p><ul><li>Quality management of deviation and complaint records and their related CAPAs</li><li>Assessment and management of change controls</li><li>Edition of QA Agreements with Zentiva third parties and subcontractors</li><li>Collection and evaluation of PQRs and stability data</li><li>Compliance evaluation of Third Parties and products</li><li>Maintenance of product database</li><li>Collection and review of CoA/CoC</li><li>QA support of product launches and transfers</li><li>GMP, GDP, MDR, HACCP, Food Supplements and Cosmetics regulations and legislations</li></ul><p>Auditing</p><ul><li>Prepare audit and audit plans</li><li>Conduct and participate to external audits</li><li>Evaluation of audit reports</li><li>Participate to internal audits and inspections</li></ul><p>KPI monitoring and reporting</p><p>Other tasks may be performed under the direction of the Manager within the agreed type and scope of work.</p><p></p><p><b>REQUIRED QUALIFICATIONS, EXPERIENCE &amp; SKILLS</b></p><ul><li>University degree in Pharmacy, Chemistry, Biology, or relevant Life Science</li><li>Minimum of 5 years in a similar role or equivalent experiences in a GMP related environment</li><li>Thorough knowledge of GMP requirements as well as knowledge of ICH and pharmaceutical regulatory requirements</li><li>Management of subcontractors is an advantage</li><li>Proven track record of project management skills</li><li>Strong communication skills and negotiation strength</li><li>Proactive attitude</li><li>Problem solving skills</li><li>Hands-on attitude, flexible and open minded</li><li>Collaborative and team-spirited</li><li>Knowledge of IT tools</li><li>Language - English: Advanced level</li></ul>