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!
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 master's 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…
Poznaj
Rezon Bio
Dołącz do zespołu ponad 1300 specjalistów produkujących zaawansowane leki biologiczne, które poprawiają jakość życia pacjentów na całym świecie.
Bazując na doświadczeniu Polpharma Biologics, Rezon Bio działa jako partner CDMO (Contract Development and Manufacturing Organization).
Dzięki nowoczesnym centrom biotechnologicznym w Gdańsku i Warszawie-Duchnicach oferujemy szeroki wachlarz możliwości karierowych w obszarach naukowych, technicznych i biznesowych.