Validation Section Head – Qualification & CSV

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>Manage all validation activities related to premises, equipment &amp; utilities qualification, calibration and computerized system validation. Oversight site compliance with data integrity.</p><p><br></p><p><strong><em><u>Duties:</u></em></strong></p><ol><li>Prepare premises, equipment &amp; utilities qualification, calibration and computerized system validation procedures, master plans and protocols.</li><li>Prepare annual plans for premises, equipment &amp; utilities qualification, calibration and computerized system validation with coordination with different departments (eg: strategic operations, supply chain, production, engineering, QC … etc).</li><li>Issue purchase requests for all department requirements required to execute premises, equipment &amp; utilities qualification, calibration and computerized system validation and ensure their availability on time.</li><li>Coordinate with different departments (eg: production, engineering, QC … etc) and with approved contractors (as applicable) the execution of premises, equipment &amp; utilities qualification, calibration and computerized system validation as per approved annual plans.</li><li>Participate in the evaluation, qualification and monitoring of outsourced activities related to premises, equipment &amp; utilities qualification, calibration and computerized system validation.</li><li>Handles any deviations or changes related to premises, equipment &amp; utilities qualification, calibration and computerized system validation.</li><li>Periodically evaluate status of qualification and validation of premises, equipment &amp; utilities qualification, calibration and computerized system validation and prepares periodic reports.</li><li>Participate in preparation of data integrity policy &amp; SOPs, data integrity risk assessment, data integrity issues investigation, data integrity gap analysis, inspection &amp; audit trail review.</li><li>Participate in different multidisciplinary teams and relevant activities as required.</li><li>Lead, coach &amp; develop subordinates.</li></ol><p><br></p><p><strong><em><u>Job Requirements:</u></em></strong></p><ol><li>Bachelor’s degree in pharmaceutical sciences, engineering, computer science or other related disciplines.</li><li>6+ years of experience in relevant field.</li></ol><p><strong> </strong>3. Training: <strong> </strong></p><p> WHO &amp; EU GMP premises, equipment &amp; utilities qualification, calibration and computerized system validation guidelines.</p>