From Graftton, we are lookin for a QC Aseptic / Microbiology Manager.

This position will be based in the south of Madrid.

Responsibilities

- Accountable for sterility assurance across site
- Contamination control strategy (leadership of the strategy: periodic review and update)
- Definition and implementation of environmental monitoring program.
- Management of trends and improvement of processes based on their results
- Parthership with QC micro lab to develop strategies of monitoring and bioburden control
- Media Fill Program (management of strategy, definition of runs, oversee of execution)
- Aseptic behaviour definition, development of training program and oversight (management). Definition of gowning strategy and cleaning processes
- Sterilization processes (suport to other departments to define sterilization strategy and oversight of execution)




- Risk assessments and improvement programs (implement/manage - against current and future expectations)
- Environmental monitoring investigations (i.e. Adverse EM trends, media fill failures)
- Review & approve any Major/Critical deviations and change proposals with Sterility Assurance impact for the assigned areas.
- Key part of audits with with regulators / clients
- Key part for new product introduction and for applicable capital projects (i.e. new lines/processes)
- Implementing best practice (i.e. ensuring understanding / compliance with updated Annex 1 - owning the transition and any risk assessments needed)
- Participant in audits to other sterile sites (CMOs) and suppliers providing microbiological service or sterile materials

📌 Aseptic Quality Manager (Casarrubios del Monte)
🏢 Grafton
📍 Casarrubios del Monte