Sterility Assurance Specialist

2 weeks ago


Singapur, Singapore 825 Glaxo Wellcome Manufacturing Pte Ltd Full time
Job Title: Sterility Assurance Specialist

At 825 Glaxo Wellcome Manufacturing Pte Ltd, we are seeking a highly skilled Sterility Assurance Specialist to join our team. As a key member of our quality assurance department, you will be responsible for ensuring the sterility of our products and compliance with regulatory requirements.

Key Responsibilities:
  • Implement and maintain sterility assurance programs on site
  • Review and approve gap/risk assessments related to sterility assurance
  • Provide quality assurance oversight to sterility assurance for site manufacturing processes and products
  • Accountable for the execution and maintenance of the environmental monitoring program
  • Provide support to value stream in matters related to sterility assurance
Requirements:
  • University degree in a relevant science or engineering discipline
  • Experience in the application of expertise and knowledge for bioburden and endotoxin control, media simulation, SHT and CCIT, sterilization methods, VHP changeover cleaning disinfection, aseptic practice, EM and utilities
  • Working or good knowledge of FDA/EU/ICH/WHO and other relevant regulatory and technical guidelines
  • Ability to take difficult and risk-based decisions based on available information
  • Fluency and proficiency in the English language
What We Offer:

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and detail-oriented individual with a passion for quality assurance, we encourage you to apply for this exciting opportunity.


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