Senior QA Operations Specialist, Small Molecules (Small Scale) 80-100% (f/m/d)
Core
Ensure compliance with quality and regulatory requirements throughout the product lifecycle and support GMP-compliant manufacturing.
Role type
Senior QA Operations Specialist (Small Molecules)
Builds
GMP-compliant small molecule products for international customers
Domain
Life Sciences / Pharmaceutical Manufacturing
Required skills
GMP knowledge, regulatory interpretation, quality risk assessment, internal/external audit execution, batch documentation review, deviation/CAPA management, customer relationship management
Preferred skills
Chemical manufacturing experience, pharmaceutical IT systems (Documentum, LIMS, TrackWise)
Technologies
MS Office, Documentum, LIMS, TrackWise
Responsibilities
Monitor compliance with quality agreements, review batch documentation for GMP compliance, support Deviations/Change Requests/CAPAs, conduct internal and customer audits, prepare Quality Review Reports
Seniority
Senior, hands-on IC