External Supply Quality Assurance Manager

Job Description

<strong><u>Job Description<br><br></u></strong>Internal Role Title: Ext. Supply Quality Assurance Manager.<br><br>Location: Cairo, Egypt<br><br>About the Role:<br><br>As an External Supply Quality Assurance Manager, you will be responsible for managing quality aspects within area of responsibility and to ensure that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements &amp; the Novartis Quality Manual, and is conducted according to the relevant Standard Operating Procedures<br><br>Key Responsibilities:<br><ul><li> Oversee all production &amp; testing activities, ensures compliance with cGxP, including data integrity and eCompliance.</li><li> Support exception investigations.</li><li> Review and approval of production, QC, and AS &amp; T records.</li><li> MBR review,</li><li> Support OpEx improvement projects Qualified Person – Executes batch release in compliance with registration.</li><li> Report technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt.</li><li> Distribution of marketing samples (where applicable).<br><br><br></li></ul><strong>Commitment to Diversity &amp; Inclusion:<br><br></strong><em>We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.<br><br></em><strong><u>Minimum Requirements<br><br></u></strong>Essential Requirements:<br><ul><li> Experience in Quality Assurance.</li><li> Knowledge of GMP.</li><li> Experience in Quality Control (QC) Testing.</li><li> Strong knowledge of Quality Standards.<br><br><br></li></ul>Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture<br><br>You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards<br><br>Commitment to Diversity and Inclusion:<br><br>Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.<br><br>Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.<br><br>Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network<br><br><strong>Division<br><br></strong>Operations<br><br><strong>Business Unit<br><br></strong>SMALL MOLECULES<br><br><strong>Country<br><br></strong>Egypt<br><br><strong>Work Location<br><br></strong>Cairo<br><br><strong><u>Company/Legal Entity<br><br></u></strong>NOV PHARMA EGY<br><br><strong>Functional Area<br><br></strong>Quality<br><br><strong>Job Type<br><br></strong>Full Time<br><br><strong>Employment Type<br><br></strong>Regular<br><br><strong>Shift Work<br><br></strong>No<br><br><strong>Early Talent<br><br></strong>No<br><br>