Quality Assurance Manager*in - GMP (m/w/d)
Core
Ensure quality assurance in a GMP control laboratory and support the GMP-compliant release of therapeutic molecules.
Role type
Quality Assurance Manager in GMP-controlled environment
Builds
Therapeutic RNA molecules and nucleic acid-based drugs
Domain
Life Sciences / Pharmaceutical Manufacturing / RNA Therapeutics
Required skills
GMP compliance, document and data review, validation and qualification, process improvement, OOS case management, audit support, training delivery
Preferred skills
GLP/GCP/ISO 13485 experience, natural sciences background
Technologies
Standard laboratory software
Responsibilities
Responsible for quality assurance in the GMP control laboratory and accompany the GMP-compliant release of therapeutic molecules; Review documents and data for quality and compliance and support validations and qualifications; Actively shape continuous improvement of processes and the quality management system; Support OOS cases, deviations, CAPAs and change-control processes; Accompany internal, external and supplier audits and conduct training for employees
