Qualitätssicherungsmitarbeiter Sterility Assurance (Mediafill) (m/w/d)
Core
Responsible for creating, reviewing, and approving GMP-relevant validation documents for aseptic process validation of sterile syringes and injection systems.
Role type
Quality Assurance Specialist (Sterility Assurance / Mediafill)
Builds
Sterile injection systems and syringes for pharmaceutical manufacturers
Domain
Pharmaceutical manufacturing / Aseptic processing
Required skills
GMP compliance, aseptic process validation, risk analysis, SOP development, audit representation, training delivery
Preferred skills
Natural science or technical degree background, long-term task-related experience in GMP environment
Technologies
MS-Office
Responsibilities
Create, review, and approve GMP-relevant validation documents; Represent quality systems during international customer and regulatory audits; Conduct on-site observations of aseptic processes; Optimize and author Standard Operating Procedures (SOPs); Perform scientific risk analyses; Act as a partner for questions regarding aseptic process validation and behavior in interdisciplinary quality optimization projects; Train staff in workshops and seminars.
Seniority
Mid-level, hands-on IC