Senior Quality Assurance Engineer

7 days ago


Suzhou, Jiangsu, China Roche Full time

Position Overview

Key Responsibilities:
1. Oversee and coordinate the monitoring of external regulatory standards, ensuring that stakeholders are informed and compliance assessments are conducted for the development of mitigation strategies. Prepare and review process documentation while considering the influencing factors across functional areas in alignment with regulatory requirements. Submit necessary manufacturing registration and reporting documents. Manage the internal audit program, ensuring adherence to established processes and maintaining the Quality Management Review process. Provide inputs for the Quality Management Review and analyze quality data to support corrective and preventive actions. Offer expertise and assistance to global teams and other sites as a China GMP specialist when required.

2. Serve as a Subject Matter Expert (SME) on the IRM process within the organization. Ensure effective implementation of digital IRM modules at RDSZ in the PIU QM Module.

3. Manage external audit processes, including coordination of authority audits and logistics preparation. Ensure readiness of documents and manage the audit environment, including the audit room and war room setup. Follow up on corrective and preventive actions post-audit.

4. Perform additional tasks as assigned by the line manager.

Qualifications & Experience:

Education:
• Bachelor’s or Master’s degree in Life Sciences, Data Science, or a related field, or equivalent experience.

Qualifications & Certifications:
• Proficient in the routine use of MS Office applications.

Experience:
• Minimum of two (2) years of experience in the Medical Device, Pharmaceutical, or Biopharmaceutical sectors.
• Proven experience in managing external audits, including interactions with regulatory bodies such as China NMPA, TUV/BSI, and US FDA.

Professional Competencies:
• In-depth knowledge of cGMP regulations applicable in Europe, the US, China, and internationally.



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