Career Category

Job Description

Position Specific Tasks

• Handle Product Complaints for Austria and act as back up for the CEE countries
• Act as functional Responsible Person back-up in Austria
• Support activities in regard to compliance with Amgen quality policies, standards and procedures and EU GDP Guideline in CEE Affiliates Maintain and use Amgen Quality Databases, country trackers and other relevant data tools
• Coordinate tracking and evaluation of KPI’s for CEE Amgen affiliates, Logistic Service Providers and Transport Service Providers
• Draft and update GDP relevant documentation ensuring that Corporate and Country Regulatory requirements are met
• Handle Deviations, CAPAs
• Manage the assessments to support Temperature excursions
• Support the Internal Quality Compliance assessments, internal audits and authority inspections in the CEE countries
• Support the training assignment process and training assignments reviews

Minimum requirements

• Academic degree in Human-, Dental- or Veterinary Medicine, Chemistry, Biology, Food- or Biotechnology
• Experience in quality assurance & quality management
•  Understanding of Quality Compliance Requirements: Good Distribution Practice (GDP), ISO 9001:2000 with the ability to interpret and apply in routine and non-routine cases
•  Computer and database skills
•  Strong analytical skills and understanding for causality
•  Languages: Fluent German and English, written and spoken
• 1-3 years of experience in Quality or Regulatory in the pharmaceutical sector

Preferred Requirements

• Ability to distinguish details in a broad and complex picture
• Excellent time management, communicational and organisational skills
• Ability to work in cross functional and intracultural environment.
• Good skills in technical writing
• Ability to maintain systems, databases and trackers
• Ability to evaluate operations according to company and regulatory guidelines (Policies / Processes / Procedures)
• Self-motivated, initiative
• Ability to work in teams and independently

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.