Aseptic Quality Leader: Sterility & Compliance

Ethypharm; Albacete; Presencial; EUR 70.000 - 90.000; Jornada completa

Descripción de la vacante

Ethypharm in Spain seeks an Aseptic Quality Manager to lead sterility assurance across the site and drive environmental monitoring and bioburden strategies. You will collaborate with QC labs, supervise media fills, and shape aseptic training, gowning and cleaning protocols to ensure compliance.

The role requires a strong background in aseptic processing, cGMP, and root cause analysis, plus experience in audits and regulator interactions.

Formación

• Bachelor degree required in a relevant area (Biology, Pharmacy, Biochemistry or similar).
• Minimum of 2 years in a pharmaceutical quality leadership function, preferably in sterile manufacturing.
• Experience in aseptic processing and sterile operations is essential.
• Experience supporting/writing OOS/OOE/OOT and deviation investigations; audits with regulators/clients.

Responsabilidades

• Accountable for sterility assurance across the site.
• Lead contamination control strategy and environmental monitoring program.
• Partner with QC micro lab to monitor bioburden and trends.
• Oversee Media Fill program: strategy, runs, execution oversight.
• Define aseptic behaviour, training, gowning and cleaning processes.
• Support sterilization strategy and cross-department implementation.
• Lead risk assessments and improvement programs; manage EM investigations.
• Review and approve major/critical deviations and change proposals.
• Participate in audits with regulators and clients; support new products and capital projects.

Conocimientos

Leadership

Auditing

cGMP Compliance

Root Cause Analysis

Technical Writing

Diplomacy

Educación

Bachelor of Science in Biology/Pharmacy/Biochemistry

Descripción del empleo

Ethypharm in Spain seeks an Aseptic Quality Manager to lead sterility assurance across the site and drive environmental monitoring and bioburden strategies. You will collaborate with QC labs, supervise media fills, and shape aseptic training, gowning and cleaning protocols to ensure compliance.

The role requires a strong background in aseptic processing, cGMP, and root cause analysis, plus experience in audits and regulator interactions.