Asymchem Group

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: 1. 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 2. 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. 3. Other Job-Related skills • Effective communication and interpersonal skills • Demonstrated experience in Microsoft Office tools www.asymchem.com