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CSL

Develops and delivers biotherapies and vaccines

Manufacturing Quality Systems Expert

Validation, Compliance & Quality SystemsPosted on Nov 10
Full-timeSwitzerlandNo salary listedIn-person

About the Job

Requirements

  • A bachelor's degree in Chemistry, Chemical Engineering, Process Engineering, or comparable scientific-technical training is required.
  • At least 4 to 5 years of professional experience in a manufacturing company is required, preferably in a regulated pharmaceutical environment.
  • Strong knowledge of GMP requirements and manufacturing processes in regulated environments is required.
  • Experience in change, deviation, and CAPA management is required.
  • Proficiency with Microsoft Office applications is required.
  • Very good written and spoken German and English are required.
  • Reliability, accountability, a structured and analytical working style, problem-solving ability, initiative, flexibility, willingness to take on additional responsibility, clear communication, collaboration, continuous learning, and the ability to give and receive constructive feedback are required.

Responsibilities

  • Create, process, and track change control requests to improve quality and EHS processes.
  • Ensure timely completion of defined measures and prevent overdue change controls, deviations, CAPAs, and complaints.
  • Prepare change requests in German and English.
  • Conduct and document complex risk assessments.
  • Support the creation, processing, and assessment of deviations in the production environment.
  • Develop, align, and implement effective CAPAs to prevent recurring deviations.
  • Create entries in the Enablon quality system and define and track CAPAs with affected departments and EHS.
  • Coordinate regularly with Quality Assurance on prioritization and the status of outstanding actions.
  • Prepare for, support, and accompany national and international regulatory-authority and customer inspections.
  • Represent the area of responsibility during audits and inspections.
  • Support qualification projects, including preparing or reviewing qualification documentation.
  • Ensure compliance with applicable GMP, quality, and EHS requirements.
  • Document EHS incidents and define and track corresponding corrective and preventive actions.
  • Prepare and present metrics and reports to the manager.
  • Collaborate with Engineering, Metrology, Quality Control, Quality Assurance, Regulatory Affairs, Research and Development, and EHS.
  • Contribute to initiatives for continuous process improvement and quality standards.

Desired Qualifications

  • Knowledge of Operational Excellence methods such as 5S, Continuous Improvement, or Predictive Maintenance.
  • Operational Excellence training, such as Green Belt or Black Belt.
  • Experience conducting or supporting GMP audits.
  • Knowledge of digital systems and tools such as SAP, MES, Power BI, or Digital Twin.
  • Experience with risk and quality management tools.

About the Company

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CSL

Develops and delivers biotherapies and vaccines

CSL is a global biotechnology company that develops and delivers biotherapies and influenza vaccines. It focuses on plasma-derived and recombinant therapies for rare and serious diseases and sells to healthcare providers, hospitals, and governments across the Americas, Asia Pacific, and Europe. Its product range includes treatments for rare diseases, influenza vaccines, and antivenoms, produced through its R&D, manufacturing, and distribution operations. CSL differentiates itself by offering the broadest portfolio of plasma-derived and recombinant therapies and by leveraging its global footprint and emphasis on diversity to reach diverse markets. The company’s main goal is to save lives and protect health by expanding access to high-quality therapies and vaccines worldwide.

Company size
10,001+
Company stage
IPO
Headquarters
Parkville, Australia
Founded
1916

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