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…
