Description
We 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.
Tasks:
Exp. from QA position; Exp. with ISO 13485, FDA 21 Part 820 regulation, GMP guidelines; Exp. with Procces validation documentation (PFMEA; URS; VMP; IQ; OQ; PQ; monitoring); exp. from production environment, if possible (processes such as purification, mixing, dialysis, filtration, concentration, cleaning) Qualifications: Engineer, Pharmacist or Chemist
What to you bring:
Minimum of 5 years experience within production in pharma or medical devices in a GMP regulated environment.
Experienced in process validation of production methods in a regulated environment.
Experienced in process documentation GMP regulated environment.
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