Third Party Quality Operations Senior Officer

<p>We are one of the leading complex drug delivery and formulation developers, using our key in-house technologies to support improved patient compliance. We service a broad partner network of hundreds ofcustomers in over <strong>80 countries</strong> throughout Europe, North America, South America, Middle East, Asia, Australia and Southern Africa.</p> <p>Our portfolio consists of over <strong>100 products</strong>, and today we are working on one of the most extensive and advanced pipelines in Long Acting Injectables, Sustained Release formulations and Preservative Free Ophthalmics, produced in our in-house US-FDA and EU-approved facilities.</p> <p>We proudly employ more than <strong>1,350 people</strong> from over <strong>24 different nationalities</strong>. We welcome the opportunity to expand our collaboration with existing partners as well as to establish new partnerships, while remaining committed to our vision <strong>“to make a difference in people’s lives”</strong> through our everyday activities and our products.</p> <p>Due to continuous growth and expansion, <strong>Pharmathen Pharmaceuticals</strong> offers a great opportunity for career development and is seeking to recruit a <strong>Third Party Quality Operations Senior Officer</strong> for the <strong>Corporate Quality Management </strong>department in our <strong>Pallini premises</strong>.</p> <p>As a<strong> Third Party Quality Operations Senior Officer</strong>, the ideal candidate will assure compliance to the GMP standards and ISO requirements by maintaining an accurate and up to date QA database.</p> <p>More particularly:</p> <p><strong>What you will do: </strong></p><p><strong>Requirements</strong></p><ul> <li>Ensure GMP compliance of products manufactured at a contract facility</li> <li>Interface with internal departments and external vendors on a variety of technical/quality subjects relevant to CMOs productions </li> <li>Participate in root cause analysis and develop project plans and/or corrective action that may impact multiple functions (including CMOs)</li> <li>Monitor contractor compliance via GxP documentation review and through the established communication channels</li> <li>Maintain Pharmathen’s Management Quality System as applicable by opening, reviewing, and / or approving relevant records of CMOs (e.g. deviations, CAPAs, Change Controls), ensuring compliance with applicable corporate and regulatory standards</li> <li>Interface with other local and corporate departments regarding registration submissions requirements and reply to deficiency letters related to products manufactured in contract manufacturers</li> <li>Assure ongoing compliance with quality and industry regulatory requirements</li> </ul> <p><strong>The ideal candidate should have:</strong></p> <ul> <li>Desirable MSc in Chemistry, Pharmacy or equivalent field</li> <li>Minimum of 2 years’ experience in Quality Management </li> </ul> <p><strong>Job-Specific Skills: </strong></p> <ul> <li>Excellent communication in English language (writing &amp; speaking)</li> <li>Computer literacy</li> <li>Ability to prioritize tasks and meet deadlines</li> <li>Exceptional communication skills </li> <li>Strong project management skills</li> </ul><p><strong>Benefits</strong></p><p><strong>What you'll gain:</strong></p> <ul> <li>Involvement in a high-caliber, team-oriented and dynamic atmosphere</li> <li>Exposure to challenging business issues and practices</li> <li>Great opportunity to leverage and develop your business knowledge and skills</li> </ul> <p><strong>Join our team and experience the unique Pharmathen’s culture that gives you the opportunity to innovate, to make decisions, to achieve your own potential and to chart your own career. </strong></p> <p><strong>Pharmathen is an equal opportunity employer. We welcome applications regardless of gender, race, age, religion, sexual orientation, and national origin.</strong></p>