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AbbVie 的使命是發現並提供創新藥物,解決當今嚴重的健康問題,同時面對未來的醫學挑戰。除了 Allergan Aesthetics 產品組合中的產品及服務外,我們還致力在幾個關鍵治療領域為人們的生活帶來顯著影響:免疫學、腫瘤學、神經科學、眼科、病毒學、女性健康和胃腸病學。如需瞭解更多有關 AbbVie 的資訊,請造訪我們的網站。在 Twitter、Facebook、Instagram、YouTube 和 LinkedIn 追蹤 @abbvie

QA Manager Biologics / Qualified Person (all genders) - permanent/fulltime

次要 路德维希港, 德国 職位 ID 2215567 類別 Quality Assurance 部門 AbbVie

The opportunity to use your full potential for a good cause? We Offer That.

Welcome to AbbVie! As part of an international company with 48,000 employees worldwide and around 3,000 employees in Germany, you will have the opportunity to work closely with us to address the health challenges of tomorrow. Do you have a passion for improving health care around the world and for using your expertise to improve patients' quality of life? In a challenging work environment that allows you to broaden and develop your own skills? You’ve found the right place! 


We're now hiring a QA Manager / Qualified Person (all genders)  for our Biologics Quality Assurance Organization in Ludwigshafen am Rhein.
You want to globally act as Qualified Person (Sachkundige Person) for Biologics Products according to § 19 German Drug Law, make difficult decisions and manage critical situations as Qualified Person with significant impact for the company?   
Then join our team and lead projects for commercialization of new products within the global organisation Biologics Region.

 

This is how you can make an impact:

  • Act as Qualified Person (Sachkundige Person) according to § 19 AMG and Annex §16 AMWHV with the responsibility to assure that globally every bulk batch/batch of biologic products has been manufactured, packaged, and tested in full compliance with the GMP requirements of the local Regulatory Authority and with the specifications in the Marketing Authorization of the importing country/product specifications
  • Ensure compliant and timely release preparation of Biologics Drug Substances, Bulk Drug, PFS and Vial in order to ensure product supply
  • Cooperate/support/lead cross functional projects in terms of product transfer and compliance initiatives
  • Plan and compile Product Quality Reviews for Biologic Products
  • Act as Quality Manager according to Site Master File
  • Support the Trend Monitoring fo Biologics Germany
  • Act as member in  globalCMC teams 
  • Manage BPDR /DPR’s and risk evaluations of high impact market complaints

This is how you make a difference:   

  • We are looking for the right talent for this role. Whether you are a Natural Scientist or Engineer, e.g. pharmacist, degree in biotechnology or if you are already qualified as QP or come with even higher qualification. You are the perfect candidate if you have the right mindset and attitude
  • Analytical thinker with hands-on mindset combined with a global view and ability to define practical solutions 
  • Ideally 5 years in production or technical support roles like QA and/or Quality Systems
  • Solid understanding on QA, QC and Quality Systems with solid knowledge of GMP, experienced in regulatory inspections
  • Team player with excellent communicational skills
  • Experienced in project management skills including definition of resolution. 
  • Fluent in English and German, both  spoken and written

What we offer: 

  • a diverse area of work where you can make a real difference  
  • an open company culture  
  • attractive remuneration 
  • intensive onboarding by a mentor  
  • flexible work models for a healthy work-life balance 
  • corporate health management with comprehensive health and exercise programs 
  • corporate social benefits 
  • diverse career options in an international organization  
  • high-level, attractive career development opportunities 
  • a strong international network  


At AbbVie, your individual contributions count – help us achieve more together. Be a part of it and grow with us – go above and beyond!  

Sounds like the perfect career opportunity for you? We look forward to receiving your application. All you need is a complete CV – anything else will be discussed in person, where possible, if general suitability is determined.  

Have questions? Email us at TalentAcquisition.de@abbvie.com – we look forward to hearing from you!  


AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.


出差: Yes, 5 % of the Time
工作類型: Experienced
工作時間: Full-time
ABBVIE

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