Quality Assurance Specialist / all genders / 2 Jahre befristet
Core
Ensuring pharmaceutical quality standards and regulatory compliance for the industrialization and market launch of biological drugs.
Role type
Quality Assurance Specialist (Biologics)
Builds
Biological drug manufacturing processes and quality systems
Domain
Biopharmaceuticals / Drug Substance Manufacturing
Deliverable
physical/clinical work
Required skills
GMP compliance, Quality Management Systems, regulatory knowledge, process validation, deviation/CAPA management, data integrity, risk management
Preferred skills
Process transfer expertise, continuous improvement methodologies
Technologies
GxP frameworks, manufacturing equipment qualification
Responsibilities
Develop and maintain quality standards for biological drugs, execute quality audits and inspections, approve manufacturing instructions and SOPs, design and participate in process validations, implement continuous improvement for data integrity and compliance, standardize workflows
Seniority
Mid-level, hands-on IC