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…