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
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