Quality Specialist North Asia (HK/TW/Korea) - Project Osprey Contractor

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Non-Standard

Job Sub Function:

Fixed Term Employee

Job Category:

Non-Standard

All Job Posting Locations:

Mongkok, Kowloon, Hong Kong

Job Description:

Oversight of Quality & Compliance and Quality Systems execution in compliance with local regulatory requirements and J&J policies and standards. north asia (HK, TW, KR)

• Ensure compliance of the Quality Management System against the company’s Quality Policies and local regulatory requirements.  Develop local process as required

• 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.

• Conduct gap assessment on global standard operating procedure to local procedures

• Prepare and review quality documentation.

• Gather data and documents for audits and inspection

• Ensure complaints handling, adverse event reporting and field actions are implemented in time and in accordance with procedure

• Ensure suppliers are qualified according to Purchasing Controls requirements

• Monitor compliance to Quality Management System and drives continuous improvements

• Ensure audit readiness according to company quality policy standards and applicable procedures (Internal Audits and External Audits)

• Support training plan administration process and document management system

•        Self-motivated, mature, pleasant personality

•        Work independently and willing to take challenges with minimum supervision

•        Good communication, presentation and interpersonal skills

•        PowerPoint and Excel analysis skills are required

•        Proficiency in spoken & written English and Chinese

 

 

Required Skills:

 

 

Preferred Skills: