QA Sterility Assurance Manager
3d ago


  • Is a sterility assurance SME who contributes to the site Local and Global sterility assurance and contamination prevention, continuous improvement and harmonization programs.
  • Provides expert coaching and mentoring support locally on sterility assurance knowledge, practices and sterility awareness as part of the developing culture for the site.
  • Responsible for the generation of key performance indicators, regulatory compliance and efficiency targets.
  • Challenges technical and scientific aspects of the facilities design and aseptic principals, with Production, QA, QC, and Engineering etc.
  • Maintenance of specific SOPs, documentation, audits, training, cGMPS and method validation for specific area of responsibility.
  • Ability to communicate quality operations and compliance perspective effectively to senior management.
  • Involvement in global harmonization / efficiency projects; begin to lead aspects of global projects within specific areas.
  • Responsibility to drive the focus on safety to the QA Sterility staff and into functional areas that routinely support biopharma manufacturing.
  • Requirements :

  • Engineering / Life Science Diploma / Degree or higher from recognized institution
  • Minimum of 7 years of QA or QC Sterile processing and Microbial experience in similar capacity
  • GMP experience in the biologics industry is required
  • Experienced in team management and leadership
  • Apply
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