Quality Specialist North Asia (hk/tw/korea) - Project Osprey Contractor

Johnson & Johnson Johnson & Johnson · Pharma · Mongkok, Kowloon, Hong Kong

Oversight of Quality & Compliance and Quality Systems execution in compliance with local regulatory requirements and J&J policies and standards for North Asia (HK, TW, KR). Responsibilities include ensuring QMS compliance, managing non-conformances, CAPAs, change controls, and audits, preparing documentation, handling complaints and adverse events, qualifying suppliers, and supporting training and document management systems.

What you'd actually do

  1. Ensure compliance of the Quality Management System against the company’s Quality Policies and local regulatory requirements. Develop local process as required
  2. Support and drive timely management of Non conformance, CAPA, Change controls and Audit Actions as per timelines. Provide guidance to the impact assessment and investigation. Monitor trends and implementation actions to ensure timely completion.
  3. Gather data and documents for audits and inspection
  4. Ensure complaints handling, adverse event reporting and field actions are implemented in time and in accordance with procedure
  5. Monitor compliance to Quality Management System and drives continuous improvements

Skills

Required

  • Proficiency in spoken & written English and Chinese
  • PowerPoint and Excel analysis skills

Nice to have

  • Self-motivated
  • mature
  • pleasant personality
  • Work independently
  • willing to take challenges with minimum supervision
  • Good communication, presentation and interpersonal skills

What the JD emphasized

  • local regulatory requirements
  • Quality Management System
  • Non conformance
  • CAPA
  • Change controls
  • Audit Actions
  • complaints handling
  • adverse event reporting
  • field actions