Aseptic Quality Manager

Ethypharm; Castilla-La Mancha; Presencial; EUR 65.000 - 90.000; Jornada completa

Descripción de la vacante

Ethypharm in Spain is seeking an experienced Aseptic Quality Manager to lead sterility assurance across the site. You will drive aseptic processing excellence, environmental monitoring, and contamination control strategies in a fast-growing pharmaceutical environment.

The role requires a Bachelor of Science in a life sciences field, at least two years in pharmaceutical quality leadership, and strong microbiology expertise.

Formación

• Bachelor of Science in biology, pharmacy, biochemistry or related field.
• Minimum 2 years in pharmaceutical quality leadership, preferably sterile manufacturing.
• Microbiology experience is essential; preferably in environmental monitoring.
• Knowledge of aseptic processing and media fills.
• Experience in supporting/writing OOS/OOE/OOT and deviations.
• Experience in supporting internal and external audits.
• Familiarity with EU Annex-1 and related guidance.
• Strong investigative and root-cause analysis skills.
• Excellent technical writing and communication abilities.

Responsabilidades

• 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
• Partnership 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 (support 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

Conocimientos

Microbiology expertise

Leadership

Investigative skills

Technical writing

cGMP compliance

Audit experience

Root cause analysis

Communication

Educación

Bachelor of Science Degree in Biology / Pharmacy / Biochemistry

Descripción del empleo

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. Our commitment is to improve patients' lives and make a positive impact on society and the environment.

Ethypharm has 1,700 employees dedicated to its various pharmaceutical activities, of which 1400 are in industrial operations. Our six production sites located in France, the UK, Spain, and China have expertise in injectables and complex oral solid forms.

With a global 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.

Ethypharm works closely with the authorities and healthcare professionals to ensure that its medicines are used appropriately and that patients have access to them.

To find out more about Ethypharm, visit and follow us on LinkedIn.

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). 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

Knowledge, Skills and Abilities:

• Involvement in capital projects (new build/refurbishment of sterile lines) would be beneficial.
• Familiarity with EU Annex-1 and other regulations and guidance.
• Strong investigative skills, preferably familiar with Root Cause Analysis methods.
• Leadership experience, and supervisory experience is helpful.
• Shown expertise with audits and client-facing roles.
• Outstanding technical writing skills
• Influencing
• cGMP Compliance
• Strong sense of diplomacy and assertiveness
• Quality Judgement

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