Sterility Assurance QA Specialist
1 month ago
Lilly is seeking a skilled Sterility Assurance QA Specialist to join our team in Suzhou, China. As a key member of our Quality Assurance department, you will play a critical role in ensuring the sterility assurance program at our Parenteral Manufacturing site meets regulatory requirements.
Key Responsibilities:- Ensure Compliance: Verify that all sterility assurance programs are implemented in accordance with regulatory guidelines and Lilly global quality standards.
- Risk Management: Identify potential risks associated with microbial contamination, endotoxin, and particulate matter, and develop strategies to mitigate these risks.
- Quality Oversight: Partner with the TSMS SA/Validation team to ensure the effectiveness of sterility assurance/validation projects and initiatives.
- Audit and Inspection: Conduct regular audits and inspections to ensure compliance with GMPs and internal standards.
- Training and Development: Provide training and coaching to shopfloor QA personnel on sterility assurance-related knowledge and procedures.
About You:
- Education: Bachelor's degree or higher in biology, microbiology, pharmaceutical science, or equivalent discipline.
- Language Skills: Excellent written and oral English communication skills.
- Work Experience: 5+ years of experience in quality assurance, preferably in a pharmaceutical manufacturing environment.
We Offer:
- Competitive Salary: ¥150,000 - ¥200,000 per annum
- Benefits Package: Comprehensive health insurance, retirement plan, and paid time off.
- Career Growth Opportunities: Regular training and development opportunities to enhance your skills and career prospects.
Contact Information:
Please submit your application, including your resume and cover letter, to us through our website.
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