Qualification Specialist

Qualification Specialist
Duchnice
Boost your career with us
Polpharma Biologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion.

Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
As a Qualification Specialist, you will be supervising and performing requalification/performance verification PVr devices in the QC, MS&T, TR&D and Production Area.
 
Your responsibilities
  • Develop qualification protocols and reports including preparation and conduct of qualification tests.
  • Perform and coordinate activities relat-ed to the requalification of equipment, facilities, clean rooms and ancillary systems.
  • Conducting Risk Analyses.
  • Provide opinions on impact of changes to qualification status.
  • Develop necessary procedures and instructions.
  • Initiate corrective and remedial actions resulting from deviations found during qualification activities.
  • Conduct activities in accordance with applicable cGMP, FDA requirements and internal procedures.
  • Supervise/perform equipment requalification/performance verification in the areas of Laboratory, MS&T, TR&D, Pro-duction.
  • Provide ongoing reports and all necessary documentation for process evaluation to supervisor and/or appropriate individuals.
  • Organizing own work and influencing the work of others to make the most efficient use of work time and completion of tasks.
  • Inform immediate supervisor of any irregularities in the process, documentation, status of tasks performed and decisions made.
  • Reporting work progress and status of completed tasks to immediate supervisor.
  • Co-operating with departments within Polpharma Biologics group.
  • Ensuring the implementation of departmental plans.
  • Supervision over qualification processes.
  • Prepare the Department for internal and external audits. Participation in all audits in subordinate area. 
If you have
  • Education: Higher technical education, Higher diploma and masters degree
  • Work experience: Over than 5 years in the Pharmaceutical Industry
  • Organizational skills and the ability to work under pressure. Decisiveness
  • Skills: good work organization, individual problem solving, good communication, team cooperation skills and being open for new tasks
  • Very good command of spoken and written English.
We offer
  • Private healthcare;
  • Life insurance;
  • Pension plan above national standards;
  • Relocation package;
  • Additional free day;
  • and more…
Why you should work with us
Contact us
career@polpharmabiologics.com
APLIKUJ TERAZ
Bieżuń Duchnice Qualification Specialist Mordy Specjalista ds. Systemów Zarządzania Jakością Polpharma Biologics Biotechnolog Duchnice

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