Position Overview
Provide end to end support to Complaint Vigilance (CV) processes primarily in Greater China through implementation of product complaint management processes, monitoring of complaints and drive improvements. This may include, but is not limited to, approval, investigation, trending and issues resolution. Support APAC CV Lead for review of complaint processes such as Complaint Vigilance Review Board, Metric, CAPA Review Board, Investigation and Audit management. The position holder must have the ability to assist with various global and regional projects within the department, communicate effectively with all levels of management.

Key Responsibilities
The position holder:

Processes product quality complaint, reviews and approves complaint in accordance with Standard Operating Procedures using the Complaints Management System. This may include, but is not limited to, review complaint case to verify customer verbatim, lot number, subject coding, trend analysis, malfunction coding, and complaint closure as applicable.
Collaborates with Call Centers, Medical Safety, Marketing, Internal affiliates, External sites, and other business partners to ensure the integrity, consistency, compliance, and alignment of the end-to-end complaint vigilance process.
Assists with developing training presentations for complaint vigilance process and systems and creation and updates of controlled documents.
Analyzes data, prepare trend reports, complaints metric and present to management and business partners as needed.
Provides periodic training and support to triage and investigation team in execution of the complaint and processes to ensure compliance to the complaint management process.

Qualification and Experience required: Master’s/ Bachelor’s degree in Pharmacy, Science discipline with a minimum of 7+ years of related experience including Quality Assurance and/or Quality Control, including experience working in pharmaceutical, medical devices or other related or highly regulated industry.
Technical Competencies: ？ Demonstrates knowledge and expertise in quality system global regulatory requirements, including ICH Q10. ？ Demonstrates understanding of medical/ product quality complaints and associated GMP compliance requirements. Able to understand/discern safety, business (legal), and compliance risks related to complaints and in achieving performance objectives / indicators. ？ Ability to develop and implement simple, yet effective quality systems and metrics ？ Ability to evaluate quality system elements and recommend improvements to meet regulatory requirements. ？ Demonstrates understanding of basic manufacturing processes and associated GMP compliance requirements ？ Strong knowledge of GMP Regulations, China FDA and local regulatory guidelines, ICH and ISO guidelines including but not limited to:, ICH Q7, Q8 and Q9, and ISO 10002, 9001, 13485, and 14971.
Requirements: ？ Demonstrated knowledge and expertise in quality processes and regulatory requirements. ？ Experience working in an FDA regulated environment. ？ Experience supporting manufacturing, packaging, and development operations.

？ Experience supporting many/all aspects of the complaint vigilance life cycle for pharmaceutical, device, and /or cosmetic products. Device and pharmaceutical strongly preferred. ？ Experience with one or more technologies supporting complaint handling. PQMS or similar system preferred. ？ Experience in the creation, update, and management of complaint files from complaint identification through closure. ？ Expertise with root cause analysis techniques including but not limited to: Brainstorming, data analysis and collection tools, 5 Whys, Fishbone (Cause and Effect), FMEA ？ Experience with tools and techniques supporting qualitative risk analysis including but not limited to: Probability and impact assessment (likelihood of recurrence and potential effect), probability and impact matrix (risk ratings, rating rules), and risk categorization (by root causes, other qualifiers). ？ Experience with systems and tools supporting analysis and reporting.

Skill ability: ？ Decision-making and problem solving: Deals with issues using deductive reasoning, critical analysis skills and systematic approaches. ？ Innovation/creativity: resourcefulness, inventiveness, or creativity is normally required to devise methods, procedures, products, scientific applications etc. Deliver value-added business results through execution and controls. ？ Possesses strong organization and project management skills supporting the ability to prioritize and manage workload and meet performance expectations. Own critical thinking, leadership skills. ？ Excellent communications (verbal, written and listening) and collaboration skills – demonstrated through work, projects, presentations, accurate information gathering, and productive discussions/results ？ Professional skills in the English language, both in spoken and written.

上班地址：漕河泾桂箐路新研大厦