Senior QA Engineer
2 weeks ago
Location: Tianjin, China
Duties & Responsibilities:
• Organizing, coordinating, to execute the quality assurance actives during the manufacturing of product and running of the quality system.
• Perform daily/weekly/monthly on-site inspection and reviewing on the operation area, operation and behaviors, document and record during the product manufacturing。
• Review the product release documentation and other quality system documentation, ensure the production and testing of each lot of released product meet the regulatory requirement, regulatory filing, pre-defined process and product spec.
• Review and/or approve minor or major change within the responsible range.
• Review and/or approve the minor, major or critical deviation within the responsible range. Participate the investigation on critical deviation and customer complaint, analyze the root cause and propose effective CAPAs.
• Approve other quality related documents as specified in the related SOPs for project management.
• Participate in the annual QA internal audit plan, organize the periodically walk-through, and report the results.
• Organize and participate in the preparation for readiness of plan for customer QA audit/regulatory inspection, participate in the customer QA audit/regulatory inspection, propose reasonable and effective action plan on the observations, follow-up the implementation on CAPAs.
• Review and approve master batch records and executed batch records to assure compliance with regulatory standards and regulatory filing.
• Be responsible for other tasks assigned by the superior.
Experience Requirements:
- Minimum Working Experiences
• Master's degree and 5 years of quality assurance in the biotechnology or pharmaceutical industry
• Bachelor's degree and 10 years of quality assurance in the biotechnology or pharmaceutical industry
- Management &Technical competencies
• Experience in pharmaceutical environment, Good Manufacturing Practices (GMP) and the applicable GxP regulations and standards.
• Knowledge of corporate quality systems that are applicable to the quality unit and the production operations service.
- Other Job-Related skills
• Effective communication and interpersonal skills
• Demonstrated experience in Microsoft Office tools
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