Johnson & Johnson Careers
[Janssen] - Business Quality Specialist (Fixed-Term Contractor)
Requisition ID: 1905769101W
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
• Degree qualified from an accredited university
TV-eFRM-00496 Job Description Version 1.0
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• 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.
• Communication Skills
• Business Relationship
• Market & Product Knowledge
• Project Management
• Regulatory Environment
• Planning & Organization
• Research & Analysis
• Strategic Thinking
• Interpersonal skills
• Ability to manage multiple projects
• Training & Development
China-Hong Kong S.A.R.-Mongkok-
Johnson & Johnson (Hong Kong) Ltd. (8060)