Quality Assurance Associate

2 months ago


Suzhou, Jiangsu, China Lilly Full time

We are seeking dedicated individuals committed to enhancing global health.

This position serves as the Quality Assurance representative for the Sterility Assurance and Environmental Monitoring teams, ensuring compliance with regulatory standards.

Key Responsibilities

  • Ensure that Sterility Assurance initiatives align with regulatory requirements and meet Lilly's global quality standards.
  • Review updates from Pharmacopeia and regulatory documents to support drug registration related to Sterility Assurance.
  • Act as a quality representative within the integrated sterility assurance team, possessing a deep understanding of the scientific principles involved in the manufacturing of sterile injectable products, including the interactions among equipment, aseptic processes, and container closure systems.
  • Undertake various Quality-related tasks, including internal and external audits, and provide support for inspection responses and recommendations.
  • Foster an open communication environment to enhance teamwork and encourage collaboration across departments; as a secondary loop QA, build strong working relationships and train on sterility-related knowledge to ensure logical evaluations and sound decision-making.
  • Strengthen and maintain the sterility assurance network with Lilly Global and develop connections with local pharmaceutical companies in China.
  • Actively engage in safety-related initiatives to promote continuous safety improvements.
  • Review or approve strategy documents, procedures, protocols, and reports related to Sterility Assurance and Validation.
  • Oversee investigations of changes and non-conformances in Sterility Assurance, ensuring compliance and effectiveness of corrective actions.
  • Apply quality risk management techniques to assess manufacturing processes for parenteral products and control potential contamination risks.
  • Collaborate with TSMS SA/Validation to provide quality oversight on sterility assurance and validation projects, ensuring compliance in various quality initiatives.
  • Participate in aseptic checks and evaluate high-risk interventions during routine production as a quality subject matter expert.

Basic Qualifications

  • Bachelor’s degree or higher in biology, microbiology, pharmaceutical sciences, or a related field (or equivalent experience).
  • Understanding of GMPs and applicable internal standards.
  • Ability to work 8-hour shifts, Monday through Friday.
  • Willingness to work overtime as needed.
  • Minimal travel may be required.
  • Adhere to HSE procedures and promptly report any discrepancies.
  • Report unsafe behaviors and conditions immediately.

Additional Skills/Preferences

  • Proficient in technical writing and presentation skills.
  • Strong written and verbal communication skills in English.
  • Excellent teamwork and interpersonal abilities.
  • Competent computer skills.

Additional Information

The applicant will work in various areas within the Parenteral Site, where some allergens may be present.

Lilly is an equal opportunity employer and does not discriminate based on 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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