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[Janssen Supply Chain ] Consultant, External Supply Integration Quality (Contractor)
Requisition ID: 00001C9O
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.
1. Position Title: Consultant, External Supply Integration Quality, Janssen Supply Chain (Contractor)
2. Sector: Janssen
3. Location: Taipei, Taiwan
The Consultant/Contract staff for External Supply Integration Quality (ESI-Q) role is to perform the role of the support for External Manufacturing sites
The ConsultantESI-Q will work with the Senior Managers/Director ESI-Q, Senior Manager/Director ESI, GTO, Quality Beerse site and other parties to:
supportDoxil/Caelyx supplied from EM and Quality improvement project at EM
ensure Quality and Compliance of J&J products produced by EMs
reduce the risk to J&J associated with the Ems
timely, efficient and cost conscious resolution of issues and release of products from EMs i.e. EM to meet market requirements.
[Key Roles & Responsibilities]
The Consultant External Supply Integration Quality will:
Plan, lead, participate, and follow up audits, due diligence, evaluations, traning and technical visits to achieve objectives listed above
Support Doxil/Caelyx supplied from EM and Quality improvement project at EM
Support EMs with quality and compliance activities including quality system assessment, monitor CAPA execution, quality agreements, deviations, product disposition, change control, product transfers, risk assessments and recalls.
Influence and build relationships with EMs and other internal parties to achieve objectives.
Report on EMs performance and issues via metrics and reports.
Provide ESI intelligence on EMs, relevant regulatories, and market related issues.
Ensure compliance with applicable J&J and Janssen Supply Chain(JSC) policy, procedure and guidance.
Meet personal, EM Quality Operations, ESI, JSC goals and objectives
Undertake consulting, training and improvement projects with EMs to achieve objectives.
Technical skills extensive knowledge of GMPs, validation, Quality systems, and Business Excellence.
Interpersonal skills to build long term relationships, influence up and down, negotiate acceptable outcomes, multiple disciplinary, cross-cultural environments in EMs and J&J.
Wide range of experience gained in at least 5 years in the pharmaceutical industry ideally including a combination of the following:
QA, manufacturing, engineering, QC, development,
solids, liquids, sterile, devices and combination dosage forms
packaging validation, process/cleaning validation, and tech. transfers.
Business and customer focus
Flexibility ability to travel across the AP region and to handle ambiguous situations, independence and self-sufficiency.
Excellent communication skills.
Fluency in Chinese and English.
Ability to quickly assimilate new technologies, perform risk assessment and develop action plans.
Understanding the business implications regarding quality positions and decisions. Influence in Matrix management.
Johnson & Johnson Taiwan, Ltd. (8580)