Quality Assurance Compliance Senior Officer (Rodopi)

<p>Founded in 1969, <strong>Pharmathen</strong> has grown to become one of the largest, vertically integrated developers of complex drug delivery technologies and is among <strong>the top 50 pharmaceutical research companies</strong> in Europe.</p><p>The company has one of the most extensive and advanced pipelines of long acting injectables (LAI), sustained release and ophthalmic formulations.</p><p>Pharmathen’s highly diversified portfolio consists of <strong>over 90 commercialized products</strong>, which are produced in its US FDA and EU-approved manufacturing facilities in Greece, serving 250 customers and accessed by patients in more than 90 countries worldwide. </p><p>Pharmathen proudly employs more than <strong>1,600 people</strong> from over <strong>28 different nationalities</strong>, with 54% of its total workforce and 66% of its Research Operations Team being female. The company’s enduring success is attributed to a passion for creativity, strong ethics, and the dedication of its people, who share a commitment to the company's vision of making a difference in people’s lives.</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 <a rel="nofollow noreferrer noopener"></a><a rel="nofollow noreferrer noopener"></a><strong>Quality Assurance Compliance Senior Officer </strong>to join our <strong>Corporate Quality Management</strong> team in our <strong>Sapes premises</strong>.  </p><p>As a<strong> Quality Assurance Compliance Senior Officer </strong> the ideal candidate will ensure compliance of all activities of the facility and warehouses with the EU cGMP requirements and ISO standards, as well as customers’ demands. He / she will keep a key role in the interdepartmental communication regarding the regulatory compliance of the facility as well as the Capa Plans of the facility related to customer audits and Authorities Inspections.</p><p>More particularly:</p><p><strong>What you will do: </strong></p><ul> <li>Ensure compliance of the Quality Management System’s Requirements according to International Standard ISO 9001 and EU cGMPs</li> <li>Communicate with customer regarding any quality queries related with the activities of the facility</li> <li>Overview the organization and monitoring of the facilities’ activities</li> <li>Take part in preparation, authorship and issuance of the Site SOPs and TDRs as well as other controlled documents of the Quality System of the company</li> <li>Follow and support the internal procedures related to Customer Audits and Inspections, Self Inspection, Monthly Oversight, Data Integrity, CAPA procedure, KPIs Monitoring and reporting, Escalation procedure, Pest Control</li> <li>Handle monitoring, archiving and notification of the main department’s processes including Internal Audits, Data Integrity and QA Oversight, Escalation Management etc.</li> <li>Support customer audits and authorities’ inspections</li> <li>Support the preparation through-out the customer audits and health authority inspection</li> <li>Support the preparation of customer CAPA plan and Health Authority CAPA plans, communicates internally with departments for the on-time implementation of the action plans and supports customer communication related to the above and any other request related to documentation</li> </ul><p> </p><p><strong>Requirements</strong></p><p><strong>The ideal candidate should have:</strong></p><ul> <li>Educational background in Chemical Engineering, Mechanical Engineering, Chemistry, Biological, Pharmaceutical sciences or other relevant sector</li> <li>Minimum 3 years’ experience in Quality Management </li> </ul><p></p><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, 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> </p><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><p> </p><p> </p>