Beschreibung
FREELANCE / PROJECT - Denmark - GMP Consultant/QA Specialist - 5 MonthsWe have a fantastic opportunity to put your comprehensive knowledge and expertise in the GMP regulated medical devices industry to work with an exciting client in Denmark!
Within a challenging setting in a highly professional quality department you will be responsible for the process validation of antibody production.
Tasks:
With your experience you will review general biological production techniques and methods, especially protein purification (chromatographic systems), protein conjugation and antibody fractioning.
Validate systems in place and review processes as well as their documentation and SOPs.
Participate in quality audits and enhance quality management systems.
Take over responsibilities as a valuable team member or project lead.
What to you bring:
Minimum of 5 years experience within production in pharma or medical devices in a GMP regulated environment.
Knowledge about general antibody purification a great advantage and highly requested.
Experienced in process validation of production methods in a regulated environment.
Experienced in process documentation for biological production techniques (GMP).
Knowledge about statistical methods an advantage and highly requested.
English at business level is a must, danish or other scandinavian languages beneficial.
This is a minimum 5 months assignment with the opportunity to extend. We are looking forward to your application and are happy to provide more details.
Real Staffing Group, Freelance Division, Frankfurt/Germany