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Support the Microbiological Quality Control Team with knowledge and technical expertise in the field of microbiological techniques and analyzes. Ensure the performance of all microbiological tests and evaluation of related records. Ensure that all microbiological tests are performed in accordance with applicable regulations and the latest knowledge. Ensure that the documentation of the Microbiological Quality Control Team is kept in accordance with the requirements of Good Documentation Practice. Ensure the implementation of appropriate transfers, qualifications and validation of analytical methods and supporting process validation. Reading and interpretation of the test results. Preparation and revision of test reports. Preparation and revision of protocols, reports, methods, procedures, instructions and other documents related to Microbiological Quality Control. Conduct quality investigations. Initiate and conduct change control. Equipment management in the Microbiological Quality Control laboratory, ensure its availability
- 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.
- 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.
- Supervision over the implementation of the environmental and clean utilities monitoring program in terms of microbiological purity and non-viable particle counting.
- Microbial identification program implementation and execution, reference strains management.
- Taking and testing samples: environmental, water, pure steam, gases, others. Samples management, registration.
- Culture media growth promotion, disinfectants efficacy testing.
- 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.
- 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).
- Minimum 10 years in Pharmaceutical, Biotechnology or related field including minimum 3 years direct experience with QMS specifically (deviations, CAPA’s, OOS’s, etc.), required for Centralized Deviation Team SME.
- Very good knowledge of GMP rules.
- Very good 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. Communicate at a professional level in reading, writing, speaking, listening in English
- Very good knowledge of MS Office.
- Private healthcare.
- Life insurance.
- Pension plan above national standards.
- Relocation package.
- International work environment.
- Additional free day.
- and more…