Aseptic Quality Lead - Sterility & Compliance

Ethypharm; Toledo; Presencial; EUR 70.000 - 95.000; Jornada completa

Descripción de la vacante

Ethypharm is seeking an Aseptic Quality Manager to lead sterility assurance across the site and drive improvements in contamination control and environmental monitoring. You will partner with QC micro labs, manage media fills, and oversee aseptic processes to ensure compliant operations.

The role requires a Life Sciences bachelor’s degree and at least 2 years in pharmaceutical quality leadership, with strong familiarity with EU Annex 1, OOS/OOE investigations, and regulatory writing for audits.

Formación

• Bachelor’s degree in biology, pharmacy, biochemistry or related field.
• Minimum 2 years in a pharmaceutical quality leadership role, ideally in sterile manufacturing.
• Strong knowledge of aseptic processing, media fills, OOS/OOE investigations, and audits.

Responsabilidades

• Accountable for sterility assurance across site.
• Contamination control strategy and oversight of monitoring programs.
• Definition and implementation of environmental monitoring program; trend analysis.
• Partner with QC micro lab to develop monitoring and bioburden control strategies.
• Media Fill Program management: strategy, runs, and execution oversight.
• Aseptic behaviour definitions, training program development and gowning strategy.
• Sterilization processes support and strategy oversight.
• Risk assessments and improvement programs against current/future expectations.
• Environmental monitoring investigations (e.g., adverse EM trends).
• Review & approve major/critical deviations and change proposals with Sterility Assurance impact.
• Key involvement in audits with regulators/clients; collaboration on capital projects.
• Implement best practice and adapt to updated Annex 1 and related guidance.
• Support new product introductions requiring sterile operations.

Conocimientos

Sterility assurance

Environmental monitoring

Root cause analysis

Leadership

Technical writing

Audits & regulatory

Educación

Bachelor of Science in Life Sciences

Herramientas

Microbiology lab techniques

Environmental monitoring systems

Descripción del empleo

Ethypharm is seeking an Aseptic Quality Manager to lead sterility assurance across the site and drive improvements in contamination control and environmental monitoring. You will partner with QC micro labs, manage media fills, and oversee aseptic processes to ensure compliant operations.

The role requires a Life Sciences bachelor’s degree and at least 2 years in pharmaceutical quality leadership, with strong familiarity with EU Annex 1, OOS/OOE investigations, and regulatory writing for audits.