Ethypharm is a leading mid-sized global pharmaceutical company that manufactures and provides essential drugs, with a focus on hospital care, central nervous system (severe pain and addiction) and internal medicine. Ethypharm has 1,700 employees dedicated to its various pharmaceutical activities, of which 1400 are in industrial operations. With a integral presence in 68 countries, the company markets its products directly in Europe and China, and has strategic partnerships in the EMEA, NA, LATAM and APAC markets.

Aseptic Quality Manager

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).



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: Bachelor of Science Degree in relevant area; Minimum of 2 years experience in a pharmaceutical quality leadership function, preferably in a sterile manufacturing site.

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 Knowledge, Skills and Abilities: Involvement in capital projects (new build/refurbishment of sterile lines) would be beneficial. Strong investigative skills, preferably familiar with Root Cause Analysis methods. Outstanding technical writing skills Influencing c GMP Compliance Strong sense of diplomacy and assertiveness Quality Judgement Do you want to know more?

📌 Head of Quality Management (Santander)
🏢 Ethypharm
📍 Santander