Creation and revision of specification documents (SOPs, test methods, work instructions) as well as planning and reporting documents for method development, transfer, verification and validation.
Technical guidance of laboratory technicians in methodology projects, including monitoring of the generated data and derivation of necessary adjustments.
Completion of the test documentation for samples, reference materials and reagents as laboratory manager, including troubleshooting and performance checks.
Handling complex nonconformities (OOX, deviations) as well as derivation and implementation of corrective actions and CAPAs including change control procedures
Presentation and discussion of documents and technical topics with customers and authorities
Participation in internal and cross-departmental projects as well as taking on on-call duties
Your profile
Completed Master's degree in Biotechnology, Biology, Biochemistry or Chemistry or an equivalent field – alternatively, a Bachelor's degree with at least 5 years of professional experience; a doctorate is an advantage.
Relevant professional experience in the field, ideally under GMP or GLP conditions, with a broad range of analytical methods.
Sound knowledge of the relevant laws and guidelines (including the Genetic Engineering Act and the Biological Agents Ordinance), as well as Excel skills beyond user level and statistical knowledge.
Good English skills, both spoken and written.
Independent and meticulous work ethic, strong teamwork and communication skills, and no intolerances to working in a laboratory or infection control laboratory.
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