Descripción de la posición

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

Education:

- Minimum required education: Bachelor of Science Degree in relevant area; e.g. Biology, Pharmacy, Biochemistry or similar.

Experience:

- Minimum of 2 years experience in a pharmaceutical quality leadership function, preferably in a sterile manufacturing site.
- Microbiology experience is crucially required for this role. (Preferably, Micro Laboratory or Environmental monitoring experience, and ideally within a sterile pharmaceutical manufacturing facility).
- Detailed knowledge of aseptic processing, and ideally will have practical experience in an active aseptic manufacturing operation. Knowledge of aseptic process simulations (media fills)
- Experience in supporting/writting OOS/OOE/OOT and deviation investigations
- Experience in supporting internal and external laboratory audits

Otras anotaciones

Para oportunidades de empleo similares visita

📌 Aseptical Manager (Madrid)
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📍 Madrid