Senior QA Engineer

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

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