QC Microbiology Expert
Gdańsk
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!
Your responsibilities include, but are not limited to:
- Development and review of procedures, validation documentation and testing methodology in the field of Microbiological Quality Control.
- Keeping of documentation in accordance with applicable procedures and GMP rules.
- Implementation and validation of microbiological methods and support process validation.
- Supervision over the proper performance of microbiological analyzes based on the guidelines of GMP, USP, Eur.Ph., local procedures and specifications in the scope of: raw materials, IPC, finished product.
- Support the implementation and execution of the environmental and clean utilities monitoring program in terms of microbiological purity and non-viable particle counting.
- Support the implementation and execution of the microbial identification program and reference strains management.
- Supervision over taking and testing samples: environmental, water, pure steam, gases, others. Samples management, registration.
- Support the culture media growth promotion, disinfectants efficacy testing, BI quality control.
- Reading and interpretation of the results of microbiological analyzes and of trend analysis.
- Initialize and conduct quality investigations (OOX / DEV / CAPA). Initiate and conduct change control.
- Plan and execute of purchases of laboratory equipment and materials to assure the lab stay operational.
- Lab materials, reagent registration and management.
- Continuous improvement, expanding knowledge through the implementation of the internal training plan and participation in external training.
- Execute of initial and periodic training as planned.
- Equipment management in the Microbiological Quality Control laboratory, ensure its availability and proper calibration and qualification status.
- Participation and representation of Polpharma Biologics in internal and external audits.
- Organizing own work in the Microbiological Quality Control Team.
If you have:
- Directional education, bachelor’s degree at least (Microbiology, Biotechnology, Biology or related).
- Minimum 5 years’ experience in regulated laboratory environment (preferred pharmaceutical or biotech industry).
- Excellent knowledge of GMP rules.
- Excellent knowledge of compendial methods: bioburden, sterility, BET.
- Excellent knowledge of issues related to media growth promotion, disinfectants efficacy study, cleanroom qualification and environmental monitoring program.
- Very good knowledge of English language. Communicate at a professional level in reading, writing, speaking, listening in English
- Very good knowledge of MS Office.
- Very good job organization and ability to prioritize tasks.
- Analytical thinking.
- Ability to solve problems and make decisions.
- Experience in participation in internal and external audits.
- Defining procedures or standards, since she has the knowledge of what the right or best way to execute a task would be.
What we offer:
- Competitive salary.
- Private healthcare.
- Life insurance.
- Private pension plan.
- Relocation package.
- 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.