Aseptic Quality Leader: Sterility & Compliance

Ethypharm; Toledo; Presencial; EUR 65.000 - 90.000; Jornada completa

Descripción de la vacante

Ethypharm is seeking an Aseptic Quality Manager to ensure sterility across its Toledo-area site. The role leads contamination control, environmental monitoring, and collaboration with QC to maintain bioburden control, media fills, and aseptic training.

Ideal candidates have a Bachelor of Science in a related field and 2+ years in pharmaceutical quality leadership, with strong microbiology and GMP knowledge. The position involves audits and capital projects supporting sterile manufacturing.

Formación

• Minimum education: Bachelor of Science in Biology, Pharmacy, Biochemistry or similar.
• Experience in sterile pharmaceutical manufacturing and quality leadership preferred.
• Experience providing audit support to regulators/clients advantageous.

Responsabilidades

• Accountable for sterility assurance across site.
• Lead contamination control strategy and environmental monitoring program.
• Coordinate with QC micro lab for monitoring and bioburden control.
• Manage Media Fill Program and runs; oversee execution.
• Define aseptic behaviour and gowning/cleaning strategies.
• Support sterilization strategy and execution across departments.
• Perform risk assessments and drive improvement programs.
• Lead investigations (OOS/OOE/OOT) and deviations.
• Participate in audits with regulators and clients.
• Support new product introductions and capital projects.

Conocimientos

Leadership

Quality assurance

cGMP compliance

Root Cause Analysis

Auditing

Regulatory compliance

Technical writing

Microbiology

Problem solving

Educación

Bachelor of Science in Biology/Pharmacy/Biochemistry

Descripción del empleo

Ethypharm is seeking an Aseptic Quality Manager to ensure sterility across its Toledo-area site. The role leads contamination control, environmental monitoring, and collaboration with QC to maintain bioburden control, media fills, and aseptic training.

Ideal candidates have a Bachelor of Science in a related field and 2+ years in pharmaceutical quality leadership, with strong microbiology and GMP knowledge. The position involves audits and capital projects supporting sterile manufacturing.