Validation – Qualification Section Head

Job Description

<p><strong><em><u>About Minapharm:</u></em></strong></p><p>Minapharm Pharmaceuticals is a leading pharmaceutical company in Egypt and the Middle East and the largest end-to-end manufacturer of biological therapies in MEA with over 20 years of experience in cellular and bioprocess engineering. Headquartered in Cairo, Minapharm commercializes over 100 life-saving and life-enhancing products ranging from small molecules to complex bioengineered proteins and viral vectors, with an impressive immunotherapy pipeline. Together with its wholly-owned Berlin-based subsidiary, ProBioGen AG – a world-leading CDMO, Minapharm has established an integrated business model making it the only gene-to-market company in the region. Consolidating its international platform of intelligent biopharmaceutical technologies with the longstanding process development and manufacturing expertise in the MEA, Minapharm, together with ProBioGen, has incorporated MiGenTra GmbH headquartered in Berlin and manufacturing in Cairo, to enhance the accessibility to critical healthcare transforming medicines through product development and commercialization of Biosimilar mABs, Cell, and Gene Therapies and vaccines, at affordable prices in Egypt, and MEA.</p><p><br></p><p><strong><em><u>Our Values:</u></em></strong></p><p>· Diversity &amp; Respect</p><p>· Integrity &amp; Accountability</p><p>· Collaboration</p><p>· Leadership &amp; Empowerment</p><p>· Innovation &amp; Continuous Learning</p><p><br></p><p>Location: 10th of Ramadan City, Egypt</p><p><br></p><p><strong><em><u>Job Summary:</u></em></strong></p><p>To ensure that the equipment, utilities, and software are qualified and remain qualified throughout their life cycle by conducting periodic evaluations.</p><p><br></p><p><strong><em><u>Duties:</u></em></strong></p><ol><li>Review the qualification protocols provided by suppliers if they are available to be executed.</li><li>Identify the gap in the equipment or software qualification document (URS, DQ, RA, IQ, QO, or PQ) and follow up on its closure with the concerned departments.</li><li>Write the qualification protocol for missing tests or establish a new document if it is not provided.</li><li>Perform or witness the qualification tests and report as necessary.</li><li>Raise the deviation observed during qualification and follow up on its correction.</li><li>Perform periodic evaluation for existing systems qualification and establish a plan for executing the gap identified.</li><li>Update the equipment / software lists with their current qualification status.</li><li>Support in other qualification related activities such as integrity testing for HEPA filters , air speed testing, air pattern testing, thermal validation, thermal mapping, and calibration.</li><li>Perform or review the performance qualification test for utilities (P.W.-compressed gas and pure steam).</li><li>Review related prices, invoices and send them to the financial department.</li><li>Calculate quality KPIs for qualification.</li><li>Prepare relevant SOPs.</li><li>Conduct on-site staff training sessions as required.</li><li>Carry out any additional job-related tasks that are assigned.</li></ol><p><br></p><p><br></p><p><strong><em><u>Job Requirements:</u></em></strong></p><ol><li>Bachelor’s degree in Engineering.</li><li>More than 9 years of experience in relevant field.</li></ol><p><strong> </strong>3. Training: <strong> </strong></p><p> · ISO/IEC 17025 (Testing and Calibration Laboratories).</p><p> · Installation and operation qualification.</p><p> · Equipment Computer System Validation.</p><p> · GAMP</p><p> · cGMP</p>