Full time, Permanent
The successful candidate will join the Bioline QA/RA group and will undertake several projects including operations equipment and process validations, including production and analytical methodologies.
Additional duties included troubleshooting and investigating of manufacturing and quality control failures, with the assistance of the production departments, writing of validation documents and participate on regulatory and production meetings.
Desirable Knowledge, Skills and Abilities:
- Experience in the qualification of analytical and manufacturing equipment (e.g. Installation, Operation and Performance Qualifications).
- Experience with validation of analytical and manufacturing processes (Operation and Performance Qualification).
- Experience in risk assessments for production processes and analytical methods.
- Experience in fermentation and down-stream processing of biomass including extraction, fractionation, filtration, chromatographic purification, filling and finishing.
- Experience with different chromatographic purification methods.
- Experience in formulation and compounding
- High standards of written work and good attention to detail
- Experience of working in a highly regulated environment, such as ISO13485/ISO9001
Mandatory Qualifications and requirements:
- MSc, Ph.D. or equivalent in life science preferably with at least 2 years relevant industrial experience
- Fluent in written and spoken English and German
- Excellent organizational and communication skills.
- Abel to work in an international team, collaborate with internal and external partners and communicate with people from different cultures.
- Good understanding and knowledge in biochemistry and analytical chemistry.
- Basic understanding and knowledge of enzymology and enzymatic analysis.
- Basic understanding of common statistical analysis
- Skilled use of computers and the ability to work with it for 8 hours
- Abel to work in a laboratory for dangerous goods for extended periods of time.
- Able to travel on company business to UK or other locations as required on a periodic basis.