(Senior) Manager Audit Coordination Quality Assurance (m/f/d)

61440 Oberursel
19.02.2020

Daten dieser Anzeige

Job-ID: 012299043
(Senior) Manager Audit Coordination Quality Assurance (m/f/d)

Fresenius Kabi Deutschland GmbH

Germany

https://jobdb.softgarden.de/jobdb/public/jobposting/applyonline/click?jp=6208687

External Supplier Audit planning for active pharmaceutical ingredients, excipients, intermediates and raw materials Allocation of auditors, subject matter experts and resources according to skills Identification of key areas to be audited Follow-up of timely submission of the reports Set up monthly report for upper management Assessment of the results, report areas for further audit focus, escalation of critical results, classification of supplier Assessment of auditor training needs Support establishment of an auditor training program Qualification and handling of 3rd party auditing companies & audit cooperation (JAVfx) Set up / Revise SOPs in the area of responsibility Performance of supplier audits as required Support implementation of an audit planning tool Administration of an external audit Sharepoint Support implementation and improvement on external Audit process (e.g. auditor qualification)

  / CAREER WITH A PURPOSE / Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. Our products and services are used to help care for critically and chronically ill patients. (Senior) Manager Audit Coordination Quality Assurance (m/f/d) - temporary Your assignments External Supplier Audit planning for active pharmaceutical ingredients, excipients, intermediates and raw materials Allocation of auditors, subject matter experts and resources according to skills Identification of key areas to be audited Follow-up of timely submission of the reports Set up monthly report for upper management Assessment of the results, report areas for further audit focus, escalation of critical results, classification of supplier Assessment of auditor training needs Support establishment of an auditor training program Qualification and handling of 3rd party auditing companies & audit cooperation (JAVfx) Set up / Revise SOPs in the area of responsibility Performance of supplier audits as required Support implementation of an audit planning tool Administration of an external audit Sharepoint Support implementation and improvement on external Audit process (e.g. auditor qualification) Your profile University degree preferably in Science, Pharmacy or Chemistry 2-4 years of experience in the pharmaceutical industry (Quality Assurance, Quality control, Auditing) Experience in GMP audits specifically for APIs (following ICH Q7) Profund knowledge in GxP regulation (China, US, PIC/s, EU) Experience in auditing Good computer skills (MS Office, Sharepoint) Fluent English language skills in speaking and writing Zusätzliche Infos   We're still hiring! Due to the current COVID-19 situation you will find important information about the application process here: https://karriere.fresenius.de/en/current-information-application-process-fresenius   Apply now Send via email Print this page At a glance Career level: Graduates, Professional Experienced Job category: Quality Management / Environment Working condition: Temporary / Full-time Business segment: Fresenius Kabi Location: Oberursel / Hessen Closing date for applications: none - we look forward to your application Apply now Send via email Print this page Your contact Teresa Martin Fresenius Kabi Deutschland GmbH Bad Homburg Ref. number: 37188 About Fresenius Career with a purpose: Over 290,000 people across the globe work at Fresenius to provide better medicine for more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career - and to become part of our impressive growth story. career.fresenius.com fresenius.com   One of Fresenius' strengths: our corporate culture for «entrepreneurs in an enterprise» where you can quickly take on responsibility. More reasons   The benefits we offer: Profit-sharing, long-term accounts for your future plans and other benefits which meet individual needs. More benefits Your contact Teresa Martin Fresenius Kabi Deutschland GmbH Bad Homburg Ref. number: 37188 fresenius-kabi.com Career level: Graduates, Professional Experienced Job category: Quality Management / Environment Working condition: Temporary / Full-time Business segment: Fresenius Kabi Location: Oberursel / Hessen Closing date for applications: none - we look forward to your application About Fresenius Over 290,000 people across the globe work at Fresenius to provide better medicine for more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career - and to become part of our impressive growth story. career.fresenius.com fresenius.com One of Fresenius' strengths: our corporate culture for «entrepreneurs in an enterprise» where you can quickly take on responsibility. More reasons The benefits we offer: Profit-sharing, long-term accounts for your future plans and other benefits which meet individual needs. More benefits

Pharma, Chemie, Med.-/ Biotechnologie

Projekt- und Produktmanagement/ Qualitätsmanagement

Sonstige Branchen

Medizintechnik/ Optik

Gesundheits-/ Sozialwesen/ Medizin

Angestellter/ Fachkraft

Vollzeit

61440 Oberursel