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Director, Head of Global Sterility Assurance

Company: CSL Limited
Location: Philadelphia
Posted on: July 1, 2020

Job Description:

We're looking for a candidate to fill this position in an exciting company.

  • Implement, maintain and continuously improve globally, the sterility assurance standards of the Quality System. These standards include but are not limited to:
  • Facility cleanliness zones incl. personnel and material flow concepts
  • Hygiene incl. gowning, cleaning and disinfection concepts
  • Clean-room behavior and aseptic techniques, operator training and qualification concepts
  • Raw material test concept
  • Environmental and utilities monitoring concepts
  • In-process control concepts and contamination control strategies
  • Sterilization and aseptic processing concepts
  • Process simulations (media fill/hold studies) concepts
  • Container closure integrity concept
  • Investigation standards for sterility test and media fill failures
  • Investigation standards for bioburden and microbial environmental / utilities monitoring excursions
  • Develops and oversees consistent trending systems
  • Develops an escalations system for trends and critical issues
  • Design, implement and own the sterility assurance risk assessment process at each manufacturing site and CMOs.
  • Present key trends, risks and issues at the Global Manufacturing Quality Management Review.
  • Maintain and share--knowledge of changes in regulatory authority requirements.
  • Graduate level in a related discipline (Microbiology, Virology, Biochemistry, and Pharmaceutical Sciences). Masters/Doctorate Qualification preferred
  • Minimum of 6 years' experience in industrial sterility assurance processes
  • Minimum of 3 years' experience leading a team with some global input
  • cGMP background in the Pharmaceutical industry
  • Experience of Quality Control microbiological testing techniques and industry practices
  • Business fluency in English
  • Proven time management skills for planning and schedule of work
  • Leadership skills in supervision of teams
  • Knowledge of continuous improvement techniques and advanced root cause analysis techniques
  • Demonstrated ability to influence at all organizational levels through clear, concise and impactful verbal and written communication skills
  • In-depth knowledge of cGMP's, FDA, TGA, EU and other relevant GxP regulations
  • Maintain in-depth knowledge of pharmaceutical manufacturing industry standards through active engagement in industry associations, e.g. PDA, ISPE etc.
  • Effective presentation and meeting skills within all levels of the organization and with external colleagues and collaborators
  • Ability to influence and motivate others while maintaining a cohesive team environment

Keywords: CSL Limited, Philadelphia , Director, Head of Global Sterility Assurance, Executive , Philadelphia, Pennsylvania

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