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Management of the Quality Control Bioassay team in the Quality Control department, cooperation with internal and external clients. Motivating employees and supporting them with knowledge and technical expertise in the field of biological techniques and analyzes. Preparation, review and approval of protocols, reports, methods, procedures, instructions and other documents related to Quality Control Bioassay in the Quality Control department. Ensuring that all necessary biological tests are performed and the related records evaluated. Accepting or rejecting tested intermediate, loose and final products, as well as the results of tests carried out. Ensuring that relevant transfers and validations are carried out. Ensuring the maintenance and qualification of rooms and apparatus in the department. Ensuring that initial and further training of staff are conducted and adapted to current needs. Selection and cooperation with contract laboratories. Participation and representation of Polpharma Biologics in internal and external audits. Keeping records in accordance with applicable procedures and GMP rules. Preparation of the annual budget necessary to carry out biological analyzes in accordance with the manufacturing process plan.
- QC Bioassay team management.
- Motivating employees towards achieving the objectives set.
- Approval of specifications, sampling instructions, test methods and other biological procedures in Quality Control departament.
- Preparation, review and approval of protocols, reports, methods, procedures, instructions and other quality control documents.
- Ensuring the performance of all necessary biological analysis and evaluation of records.
- Timely acceptance or rejection of tested intermediates, products in bulk and final products and their results of analysis.
- Timely and reliable performance of analysis. Siginig of Certificates of Analysis.
- Ensuring of performance appropriate verifications of pharmacopea's methods.
- Higher education (microbiology, biotechnology, biology, chemistry or related).
- Minimum 5 years of experience in laboratory work in regulated laboratory environment.
- Practical and theoretical knowledge about transfer and validation of analytical methods, stability studies, biological methods e.g. ELISA, pharmacopoeal methods used for release intermediates and final drug product.
- Very good knowlegde of GLP and GDP rules and ability to conduct them in laboratory and supervice compliance with these rules.
- Communicative knowledge of English.
- Very good abilities to organizing team's and own work and ability to work under time pressure.
- Very good cooperation with others in order to solve the problems.
- Timelines, ability to prioritize tasks.
- The ability of analytical thinking.
- Good knowlegde of MS Office.