Aseptic Quality Manager

Ethypharm; Albacete; Presencial; EUR 70.000 - 90.000; Jornada completa

Descripción de la vacante

Ethypharm in Spain seeks an Aseptic Quality Manager to lead sterility assurance across the site and drive environmental monitoring and bioburden strategies. You will collaborate with QC labs, supervise media fills, and shape aseptic training, gowning and cleaning protocols to ensure compliance.

The role requires a strong background in aseptic processing, cGMP, and root cause analysis, plus experience in audits and regulator interactions.

Formación

• Bachelor degree required in a relevant area (Biology, Pharmacy, Biochemistry or similar).
• Minimum of 2 years in a pharmaceutical quality leadership function, preferably in sterile manufacturing.
• Experience in aseptic processing and sterile operations is essential.
• Experience supporting/writing OOS/OOE/OOT and deviation investigations; audits with regulators/clients.

Responsabilidades

• Accountable for sterility assurance across the site.
• Lead contamination control strategy and environmental monitoring program.
• Partner with QC micro lab to monitor bioburden and trends.
• Oversee Media Fill program: strategy, runs, execution oversight.
• Define aseptic behaviour, training, gowning and cleaning processes.
• Support sterilization strategy and cross-department implementation.
• Lead risk assessments and improvement programs; manage EM investigations.
• Review and approve major/critical deviations and change proposals.
• Participate in audits with regulators and clients; support new products and capital projects.

Conocimientos

Leadership

Auditing

cGMP Compliance

Root Cause Analysis

Technical Writing

Diplomacy

Educación

Bachelor of Science 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
• cGMP Compliance
• Strong sense of diplomacy and assertiveness
• Quality Judgement