Quality Assurance Manager GMP/GCP (m/f/d)

Our client is a NASDAQ listed biotechnology company with the global Headquarter in Germany. The companies focus is the research and development of new medicines for the treatment of inflammatory diseases within a global development approach. Our client stands out for an excellent team of highly motivated and skilled individuals who put strong emphasis on a team effort

 

To support their expanding Quality Assurance Team we are looking for a:

Quality Assurance Manager GMP/GCP (m/f/d)

  • Bereich:

    Medical

  • Berufssparte:

    Qualitätswesen/Qualitätsmanagement

  • Arbeitsregion:

    München

  • Art der Anstellung:

    permanent

  • Kennziffer:

    26656

  • Aktualisierung:

    2021-06-03

Haben wir Ihr Interesse geweckt?

Dann bewerben Sie sich gleich hier Online oder per E-Mail unter Angabe Ihres frühestmöglichen Eintrittstermins und Ihres Gehaltswunsches.


Your tasks

  • Ensure the maintenance and continuous improvement of the company's quality management system and Check of (laboratory) data and documentation

  • Management of temperature excursion (incl. evaluation and determination of impact on concerned IMP)
  • Providing Quality Assurance support for validation activities associated with analytical methods, equipment and computerized systems
  • Monitoring and processing of deviations, change controls, risk analyses etc.
  • Assistance in processing of complaints and recalls
  • Monitoring and processing of corrective and preventive actions (CAPAs)
  • Planning, preparing, conducting, reporting and follow-up of internal audits
  • Vendor qualification incl. planning, preparing, conducting, reporting and follow-up of external audits (Contracted Laboratories, Contracted Research Organizations, Contracted Manufacturing Organizations, etc.)
  • Management of Quality Documents (SOPs, working etc.) according to the respective written procedures
  • Coordinating, conducting and tracking of GxP-relevant training of new and existing staff incl. development of training materials and applicable measures of success control
  • Create, maintain and revise departmental Quality Documents
  • Providing support and participating in authority inspections.

Your qualifications

  • Academic degree in life sciences or comparable study or related disciplines or equivalent experienced gained by working in a relevant area
  • 3+ years’ experience in the field of quality assurance/ quality management especially in the area of clinical development as well as the commercial stage preferred
  • Thorough understanding of the drug development process
  • Thorough understanding of national and international laws, relevant GxP regulations and guidelines (e.g. Good Clinical Laboratory Practice, Good Clinical Practice, Good Manufacturing Practice, Good Distribution Practice)
  • High level of quality awareness
  • Excellent interpersonal, verbal and written communication skills
  • Fluent in written and verbal English and German
  • Highly motivated, self-driven and dependable
  • Strong sense of responsibility, accuracy and attention to detail
  • Ability to manage multiple and varied tasks, and prioritize workload
  • Sound knowledge of MS Office applications (basic knowledge of Office 365 Cloud applications)
  • Willingness to travel (national and international traveling) is required.

Your contact person

Osmarina Pereira
Senior Personalberaterin

Address

Optares Medical GmbH & Co. KG
Osmarina Pereira
Heiligengeist Höfe 8
26121 Oldenburg