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

www.asymchem.com