Full Time

QA Specialist

Posted 2 months ago
Application ends: November 3, 2021
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Job Description

Scope

The position is responsible for regulatory compliance and quality assurance of CooperVision China in accordance with NMPA Quality Management System requirements. It covers key areas including QMS establishment and maintenance, distributors qualification review, 3PL monitoring and supplier management, inspection assistance, and system and record maintenance.

Job Summary

The position is required to work closely with global RAQA, global manufacturing facilities, local commercial team, external customers/consumers, and regulatory authorities (if applicable) to ensure an effective and efficient quality management system to support regulatory compliance and quality assurance of CooperVision China. Key responsibilities include QMS establishment and maintenance, distributors qualification review, 3PL monitoring and supplier management, inspection assistance, and system and record maintenance. The position also covers part of packaging/labeling management.

Essential Functions & Accountabilities

  • QMS documents and records maintenance
  • Responsible for continuous Quality Management System efficiency and effectiveness of CV China
  • Liaise with global/regional QA to ensure the China local QMS is aligned with global and regional settings and guidance
  • Support implementation of quality initiatives by promoting and developing quality awareness in every employee, sustain and improve regulatory/compliance-oriented initiatives
  • Distributors Qualification Review
  • Manage the qualification of CooperVision China customers/distributors
  • 3PL monitoring and supplier management
  • Coordinate with 3PL to ensure daily operation is in compliant and effective manner to support business
  • Monitoring 3PL performance and quality KPIs, investigate continuous improvement opportunities
  • Support line manager to perform qualifications of economic operations like packaging/labeling suppliers, private label suppliers, and monitor their quality performance in daily operations
  • Packaging/Labeling Management
  • Develop the Chinese labeling with RA and Marketing teams to ensure the compliance of NMPA regulatory requirements
  • Implement packaging/labeling procedures through VP/PCO/NPLCO processes to ensure timely and compliant switch
  • Address any issue or query from internal and external stakeholders
  • Others
  • Assist in authorities’ inspections
  • Assist management for DOEO (Documents of External Origins) and intelligences collection, interpretation, training and implementation in accordance with external and internal requirements
  • Responsible for an effective regulatory and quality record management system internally
  • Other regulatory compliance and quality assurance tasks assigned by management

Travel: < 5%

Qualifications

Knowledge, Skills and Abilities:

  • Basic knowledge of NMPA QMS related regulatory requirements
  • Strong patience and high sense of responsibilities
  • Detailed oriented, well-organized, and strong logical thinking
  • Intermediate skills of office software
  • Moderate in reading and writing in English

Wo Rk Environment

  • General office environment
  • Flexible hours to support the international nature of the job

Experience

  • At least 1 year regulatory compliance and quality assurance experience in relevant areas, pharmaceutical/medical device industry is preferred
  • Experience in the communications in international organization

Education

  • Bachelor degree or above
  • Related majors (e.g., life science, medical technology, bioengineering, etc.) is preferable

Job

RAQA

Primary Location

China

Organization

CVI Quality Assurance Manufacturing

Schedule

Full-time

Unposting Date

Ongoing