Quality Assurance Specialist - fixed-term
Core
Ensuring quality and regulatory compliance within sterile and aseptic pharmaceutical manufacturing, with a focus on SAP processes and artwork/packaging approval.
Role type
Quality Assurance Specialist
Builds
Sterile and aseptic contrast media
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
GMP compliance, SAP system proficiency, artwork and packaging approval, data analysis, procedural documentation, audit participation, training delivery
Preferred skills
Deviation management, CAPA, change control, LEAN principles, risk management
Technologies
SAP
Responsibilities
Ensure compliance with GMP requirements and quality standards; Perform quality-related assessments and approvals in SAP; Approve artwork, labels, and packaging materials; Provide QA support to manufacturing and labs; Analyze quality data and trends; Prepare and approve GMP documentation; Participate in audits and regulatory inspections; Support training in GMP and data integrity.
Seniority
Individual Contributor
