Responsibilities / Duties:

• Performs protocol, data, report, and in-lab phase inspections for a specific study type to verify conformance to applicable SOP and regulatory requirements.

• Evaluates responses to inspection reports and performs follow-up with respondents, management, or others, if needed, to ensure resolution.

• Ensures that systems used in QA are properly maintained (e.g., QA audit records, training records).

• Notifies management of service failures.

• Manages all aspects of personal, daily micro-scheduling, organization and prioritization related to a full workload.

• Performs study sign-off including but not limited to QA statement preparation (internal/external) and report finalization.

• Performs SOP reviews for specific study type.

• Starts to participate in internal facility and supplemental inspections, under supervision.

• Starts to deliver basic quality/regulatory training, under supervision.

• Identifies opportunities for process improvement and harmonization efforts that promote best practices.

• Performs other related duties as assigned.

  
  

  Education / Qualifications
  

• Bachelor of Science/Arts (BS/BA) degree; degree in a science field is preferred (e.g. chemistry, biology, animal science)

Experience

• At least 2 years of experience as a quality auditor in a GxP-regulated environment or at least three years working experience in GxP regulated environment.

Location: 上海浦东新区康新公路3377号

上班地址：浦东新区伽利略路338号9号楼