Johnson & Johnson is the world's most comprehensive and broadly based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices and diagnostics markets and have the skills...

Johnson & Johnson is the world's most comprehensive and broadly based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices and diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.

[Janssen] - Business Quality Specialist

Job level Entry
Work exp 2 Years To 4 Years
Education Bachelor Degree
Professional Qualification CAPA, GxP
Skill CAPA, GxP
Language Chinese - Cantonese, English
Location
Mongkok
Employment type Permanent
Benefits 13-month pay, 5-day week, Dental plan, Insurance plan, Maternity leave, Medical plan, MPF
Industry Medical Services / Pharmaceutical / Hospitals
Job function Manufacturing > Quality Assurance / Control
Published On 05/09/2019

Overall purpose of job:

Responsible and owner for the implementation of Quality Management System (QMS) for all GXP related activities (pre- and post-marketing) at the LOC level, to ensure that the implementation meets the requirements of J&J Quality Policy, Quality Standards, LOC Quality Manual, applicable regulations and to ensure the QMS is appropriately maintained.
 
 
Essential duties and responsibilities:
• Reports to Quality Head of Hong Kong
• Assist with implementation of Quality Management System to local operating company
• Perform product inspection and releases according to approved specification
• Support in communication and activities with external distributor and/or suppliers
• Responsible to monitor and update the local operating company quality manual
• Ensure audit readiness according to company quality policy standards and applicable procedures.
• Support internal and external audit; conduct audit to distributors, 3rd party service providers, GxP related suppliers and POLO suppliers.
• Responsible for monitoring of purchasing control and supplier management program; monitor and update the Approved Supplier List (ASL)
• Assist in the documentation of corrective actions plans (CAPAs) and monitor implementation
• Provides oversight/monitor complaints handling, quality issue reporting, field actions, change management, risk management, document management, and qualification & training program are implemented and in accordance with company and/or health authority guidelines
• Conduct gap assessments on global standard operating procedures to local procedures
• Create local implementation documents for procedures that’s deviated from global SOPs
• Assist in preparation and oversight of escalation management to and from regional/global office
• Assist with preparation of Quality System Management Review
• Understands and ensures continued compliance to global and local regulatory requirements on assigned responsibilities
 
Requirements:
• Degree qualified from an accredited university
TV-eFRM-00496 Job Description Version 1.0
Page 2 of 2
• For Business Quality Executive, minimum of 2 – 4 years of experience in quality in pharmaceutical or related industry
• Results oriented and able to independently create and deliver
• Knowledge and understanding of end to end supply chain processes and GxP requirements in business environment is a plus.
• Good interpersonal and communication skills who can interface, collaborate and influence stakeholders.
• Willing to work occasionally at different time zones.
• Minimum of travel may be required.
 
 
Essential –
• Communication Skills
• Business Relationship
• Market & Product Knowledge
• Project Management
• Regulatory Environment
• Planning & Organization
• Research & Analysis
• Strategic Thinking
 
Important –
• Interpersonal skills
• Ability to manage multiple projects
• Training & Development