Quality Control 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!
Role:
In this key position you will support the Microbiological Quality Control Team with knowledge and technical expertise in the field of microbiological techniques and analyzes, as well as transfers and validations of methods, supervising quality investigations and change controls, reviewing and approvals of relevant documentation.
Your responsibilities
- Development and review of procedures, validation documentation and testing methodology in the field of Microbiological Quality Control
- Development and review of testing strategies and sampling plans in terms of Microbiological Quality Control
- Supervision over the keeping of documentation in accordance with applicable procedures and GMP rules
- Supervision over the implementation and validation of microbiological methods and supporting 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, and finished product
- Supervision over the implementation of the environmental and clean utilities monitoring program in terms of microbiological purity and non-viable particle counting
- Supervision over the quality control of microbiological culture media and disinfectants
- Supervision of the reading and interpretation of the results of microbiological analyzes and of trend analyses
- Performing the function of an administrator of computerized systems for Microbiological Quality Control devices
- Conducting and supervising quality investigations (OOX / DEV / CAPA)
- Initiating and supervising change controls
- Continuous improvement, expanding knowledge through the implementation of the internal training plan and participation in external training
- Participation in internal and external audits and representation of Polpharma Biologics
If you have
- University degree (Microbiology, Biotechnology, Biology or related)
- Minimum 5 years of experience in regulated laboratory environment (preferred pharmaceutical/ biotech industry)
- Excellent knowledge of GMP
- Excellent knowledge of compendial methods: bioburden, sterility, BET
- Very good knowledge of issues related to media growth promotion, disinfectants efficacy study, cleanroom qualification and environmental monitoring program
- Very good knowledge of English language
- Very good knowledge of MS Office
- Very good job organization and ability to prioritize tasks
- Experience in participation in internal and external audits
- Analytical thinking skills
- Teamwork skills
- Ability to make decisions and solving problems