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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
Documentation Coordinator

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

 

 
We are waiting just for you!


 
 

 Main Responsibilities:

  • Supervision and coordination of the Documentation Team and ensuring quality compliance within the Technical Operations Department
  • Supervision of the aforementioned Department’s documentation, adaptation of procedures and system documentation to the user’s needs while meeting GMP requirements
  • Supervising and coordinating preparation and updating of system documents, procedures, instructions and related documentation in accordance with GMP requirements
  • Conducting and / or supervising training sessions for employees
  • Participation in internal audits, inspections, audits of service providers and material providers related to the production of both active substance and finished product
  • Supervision and participation in the preparation of calibration, qualification, maintenance, preventive or repair schedules
  • Supervising timely implementation of CAPA activities, tasks related to controlling changes and processing deviations
  • Supervision of hygiene in production, technical and storage areas
  • Participation in risk analysis and risk analysis planning

Role Requirements:

  • Higher education with specialisation in the fields of biotechnology, biology, pharmacy or related
  • Min. 5 years of experience working with GMP documentation in pharmaceutical or biotechnological company
  • Min. 3 years of practical experience working with deviations, CAPA, change control, creation of quality documentation, revision of process documentation or other documentation
  • Min. 2 years of experience in team management role
  • Good knowledge of cGMP and FDA requirements
  • Experience in GMP / FDA audits / inspections and other audits/inspections
  • Very good command of English in speaking and writing
  • Experience working with biological drugs and experience in the use of disposable materials for the production of biotechnology drugs will be considered an additional asset
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