Manager Quality Assurance (gn) Computerized System Validation (CSV)

82152 Planegg, 82152 Krailling, 82152 Planegg
19.11.2019

Daten dieser Anzeige

Job-ID: 011629979
Manager Quality Assurance (gn) Computerized System Validation (CSV)

MorphoSys AG

Germany

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Plan, conduct, follow up audits of GxP relevant computerized systems at our external vendors (e. g. Contract Manufacturing Organizations, Contract Research Organizations, distributors etc.) Plan, conduct and follow up audits of in-house GxP relevant computerized systems, and IT infrastructure Host and follow-up authority inspections QA specific oversight and support of Computerized System Validation projects Represent Quality Assurance in GxP Computer System Validation projects Write & review SOPs Manage continuous improvement of CSV related Quality Management System Provide QA related CSV support, advice, and training to internal departments and stakeholders

MorphoSys' mission is to make exceptional, innovative biopharmaceuticals to improve the lives of patients suffering from serious diseases. Innovative technologies and smart development strategies are central to our approach. Success is created by our people, who focus on excellence in all they do, collaborate closely across disciplines. We all are driven by a desire to make the medicines of tomorrow a reality. Guided by mutual respect and trust, each member of the MorphoSys team is given the opportunity to develop and flourish within this exciting and inspiring environment. Join us in Planegg near Munich! We would like to fill the following vacancy as soon as possible: Manager Quality Assurance (gn) Computerized System Validation (CSV) Your Responsibilities: Plan, conduct, follow up audits of GxP relevant computerized systems at our external vendors (e. g. Contract Manufacturing Organizations, Contract Research Organizations, distributors etc.) Plan, conduct and follow up audits of in-house GxP relevant computerized systems, and IT infrastructure Host and follow-up authority inspections QA specific oversight and support of Computerized System Validation projects Represent Quality Assurance in GxP Computer System Validation projects Write & review SOPs Manage continuous improvement of CSV related Quality Management System Provide QA related CSV support, advice, and training to internal departments and stakeholders Your Requirements: Four to five years of professional experience as Quality Assurance Computer System Validation professional in pharmaceutical/biotech industry Experience in software validation projects such as eTMF, quality management software, electronic data capture software etc. Experience as auditor Expert knowledge of national and international regulations and standards, e. g. 21 CFR Part 11, Annex 11, GAMP5 Good knowledge of relevant cGMP and GCP regulations/guidelines Well-organized, structured person Excellent communication skills, fluent in German and English (written and spoken) Flexible, highly motivated, with strong organization skills Team player with well-developed interpersonal abilities Able to work independently and solution-oriented Excellent application of office software (Word, Excel, PowerPoint and SharePoint) We offer: Creative working in X-functional teams Open and appreciative corporate culture Multicultural environment Working in an attractive, high-quality equipped building with restaurant Free sports and language courses Thank you for your interest! We are looking forward to receiving your pertinent application docu­ments. For your application please use exclusively our career portal www.morphosys.com/careers/job-opportunities. We offer not only excellent career prospects, but also support you from the very beginning - even helping you move if necessary. MorphoSys AG, Semmelweisstraße 7, 82152 Planegg

Pharma, Chemie, Med.-/ Biotechnologie

Projekt- und Produktmanagement/ Qualitätsmanagement

Chemie/ Pharma/ Biotechnologie

Angestellter/ Fachkraft

Vollzeit

82152 Planegg

82152 Krailling