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if you want to work:

in one of the most modern biotechnology
centres in Europe
 
in place where profesionals
from all over the world work
on the highest-quality equipoment
 
in the production
of biotechnological
drugs, which dive access
to effective therapy to
more patients
 
in a company that will dive you stable employment competetive remuneration attracive benefits and the opportunity to participate in training at home and abroad
 
Currently we’re looking for
Senior Qualification Specialist

Join “start-up” Biologics division with strong international and local team at site!

 

 
We are waiting just for you!


 
 

What will your job be?

  • Preparation of qualification documentation: qualification plans, protocols and reports
  • Conducting the qualification tests related to Production/Process Equipment or Quality Control Equipment
  • Initiating and leading the Risk Assessments
  • Monitoring and supervision of system documentation related to qualification activities
  • Conducting trainings on procedures for qualifying activities
  • Conducting activities in accordance with the applicable cGMP, FDA and internal procedures
  • Overseeing the qualification status of equipment and production installations
  • Initiating corrective actions resulting from deviations identified during qualification activities
  • Verification of the qualification documentation and comparison of the obtained results with the acceptance criterion
  • Revising validation and qualification documentation of the Direct Impact Systems

 

 

What do we expect from you?

  • Higher directional education (biotechnology, biology, pharmacy or technical related fields)
  • Knowledge of the cGMP and FDA regulations
  • Experience with production/ process or quality control equipment
  • Experience in developing qualification documentation in accordance with GDP and GMP principles
  • Experience in conducting qualifying activities on Risk Assessments, DQ, IQ, OQ and PQ
  • Ability to recognize and solve problems independently, good organization skills, ability to work efficiently under time pressure
  • Fluent English
  • Flexibility, communication skills, teamwork spirit
Aplikuj