JOB DESCRIPTION:
- Preparation and revision of quality procedures/ instructions/ validation documentation and microbiological methods.
- Validation of microbiological methods and participation in the production processes validations in terms of microbiological quality control
- Performing research and analysis based on the standards, specifications, pharmacopoeias and the principles of GMP and GLP in order to provide information about the tested product and raw materials
- Keeping records as per GDP standards
- Reading and verification of microbiological results and data interpretation. Trend analysis.
- Initiating quality investigations and participating in CAPA implementation in terms of microbiological quality control
- Change control processes initiation and cooperation during implementation in terms of microbiological quality control
- Laboratory equipment supervising
- Taking and testing samples: environmental/clean room monitoring, water, clean steam, gases, raw materials, in process materials, end products
- Preparation and filling of documentation connected with documentation of results, procedures, reports
- Qualification of laboratory equipment, validation and verification for microbial methods
EXPECTATIONS:
- Higher directional education in Microbiology, Biotechnology, Chemistry or related
- Very good knowledge of GMP, GLP & GDP
- Knowledge of microbial methods: Bioburden (water, product), endotoxin test (water, product), QC of media, Microorganisms identification
- Experience in participation in internal and external audits
- Very good knowledge of English language
- Mobility - willingnes to work in two differnet locations
WE OFFER:
- Employment contract with opportunity to help shape the success of a leading private pharmaceutical company
- Working in a cutting edge biotech laboratory
- Great opportunity for professional development and participation in training programs
- Competitive salary, performance-related bonus and attractive fringe benefits
