Aseptic Quality Assurance Specialist

1 month ago


Suzhou, Jiangsu, China Lilly Full time

We are seeking a highly skilled and experienced Aseptic Quality Assurance Specialist to join our team at Lilly.

The successful candidate will be responsible for ensuring the sterility assurance program in Suzhou Parenteral Manufacturing site is compliance with regulatory requirements.

Main Responsibilities:

  • Ensure Sterility Assurance programs meet agency guidelines and Lilly global quality standard requirement.
  • Review Pharmacopeia updates and Regulatory Documents for submission for the portions related to Sterility Assurance supports.
  • Participate in the resolution of integrated complicated events and issues in the factory's comprehensive sterility assurance team.
  • Complete other tasks related to Quality, such as internal/external audit, including support inspection response and sharing of recommendations.
  • Maintain open communications and promote teamwork and employee participation in the work group with other departments.
  • Partner with TSMS SA /Validation and provide quality oversight of sterility assurance/validation projects and improves initiatives.
  • Participate in the site aseptic check, review and approve high-risk non-coded interventions and associated controls.

Basic Requirements:

  • Bachelor degree or above in biology, microbiology, pharmaceutical science or equivalent science discipline.
  • Understanding of GMPs and applicable internal standards.
  • Ability to work 8 hours days-Monday through Friday.
  • Overtime may be required.
  • Minimal travel required.
  • Follow all HSE procedures.

Additional Skills/Preferences:

  • Technical writing and presentation skills.
  • Good and strong written and oral English communication skills.
  • Good teamwork and interpersonal skills.
  • Good computer skills.

Lilly is an equal opportunity employer. We do not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. #WeAreLilly



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