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QA Coordinator in a Biotech Company Focused on the Discovery, Design and Development of Innovative Peptide-Based Medicines

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QA Coordinator in a Biotech Company Focused on the Discovery, Design and Development of Innovative Peptide-Based Medicines Join us for a better future Be the new QA Coordinator in a biotech company focused on the discovery, design and development of innovative peptide-based medicines Zealand Pharma A/S (Zealand) aims to become a fully integrated biotechnology company leading in delivery of specialty medicines. We are passionate about improving the quality of life for patients with metabolic and gastrointestinal diseases, and other specialty or rare disease areas with significant unmet medical needs. In the QA team, we are now looking for a new colleague to help us build and maintain the structure in our quality system and to secure follow-up activities. The position will report to VP Quality. Ensure tracking and timely follow-up on quality related documentation hereunder deviations, change controls, audits and batch related documentation Maintain and track updates to Zealand’s Quality Management System Become superuser of the Quality Module in our validated electronic system, covering change management, deviation and CAPA management and audit & vendor management Become the QA superuser of Zealand’s EDMS system Ensure routine KPI reporting to management on training, SOP finalization, and relevant Quality topics Be an active part of records management and data governance in QA Assist in the planning and follow-up of the quality audit program Managing the Quality Management Review – drive the process, compile data and prepare for routine QMR including documentation and follow-up Prepare relevant batch related documentation in connection with release. Job Profile The successful candidate will be: Pragmatic and yet with a compliant quality mindset Have high standards for ethics and integrity High degree of structural skills and ability to transform them to practical solutions Strong communication skills verbally as well as in writing Energy and drive for team results, consistent high-performer Ability to work effectively in a fast-paced environment Enjoy being in a great team and achieve things together Fluent in English (company language) and Danish. Zealand Pharma A/S 1/2 Candidate Profile The successful candidate will have: 5+ years in experience with quality systems in the pharmaceutical/biotech industry Education as Pharmaconomist, lab tech, Bachelor of Pharmaceutical science or similar Strong practical knowledge of GxP Quality Systems in development. What we offer Zealand’s employees are one of the company’s most important assets. We strive to attract, develop and retain the best talents, and to be a company where every employee can thrive. At Zealand, we understand the value of a diverse workforce. As an employee, you will be part of an innovative, cross-disciplinary and cross-cultural working environment. We offer a combined salary package including pension scheme and health insurance, as well as the option of joining the company lunch program, and use of massage, fitness and social facilities. To find out more about working at Zealand, visit our careers site and view our company video at: www.zealandpharma.com/zealand-as-a-work-place/ www.zealandpharma.com/video-about-zealand-new/ About Zealand Pharma A/S Application Zealand Pharma A/S (Nasdaq Copenhagen and Please send your application and CV no later than May 26, New York: ZEAL) ("Zealand") is a biotechnology 2019 to: company focused on the discovery and development of innovative peptide-based [email protected] medicines. More than 10 drug candidates invented by Zealand have advanced into clinical or development, of which two have reached the market. Zealand’s current pipeline of internal Zealand Pharma A/S product candidates focus on specialty Att.: HR gastrointestinal and metabolic diseases. Zealand’s portfolio also includes two clinical Smedeland 36 license collaborations with Boehringer Ingelheim DK-2600 Glostrup and pre-clinical license collaboration with Alexion Pharmaceuticals. For further information, please contact VP Quality, Charlotte T. Rezai Zealand is based in Copenhagen (Glostrup), Denmark. For further information about the at +45 5060 3686 Company's business and activities, please visit www.zealandpharma.com or follow Zealand on LinkedIn or Twitter @ZealandPharma. Zealand Pharma A/S 2/2 .
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