Johnson & Johnson Careers

Senior Engineer, Supplier Quality

Petaling Jaya, Malaysia
Quality Assurance


Job Description

Requisition ID: 1805622077W

  • Quality & Compliance Management of Local, Regional and Global suppliers (All suppliers to Malaysia, Singapore and Philippines business).
  • Supplier GMP/Quality Audits planning and coordination.
  • New Supplier selection, qualification, approval and certification
  • Development and implementation of strategic work plan for Supplier Quality Management of the Categories led.
  • Rolling out Global & Regional quality initiatives (e.g. SQE2 /Technical Assessment initiatives).
  • Act as quality support for Business Continuity Projects and Gross Profit Improvement projects.
  • Quality Agreements- Manage the quality agreements for the region by coordinating with country leads. Ensuring all quality agreements are timely signed-off.
  • Oversight and management of Change Approval/Non-conformance Management & Investigation Approval.
  • Manage/lead from supplier quality on new product development projects and other quality improvement projects.
  • QMS Implementation in AP Supplier Quality Conduct thorough gap analysis of AP SQM practices Vs applicable policies, Standards, WWSPs, QSPs, SOPs & prepare action plan and execute the same to close the gaps successfully.
  • Ensure the supplier related issue is escalated to Management per J&J procedure and support Regional/local team to solve the issue.
  • Review and approve CAPA of supplier to ensure effectiveness of investigation and action plans. Raise high risk quality issue and NC trend to Supplier’s Management and ensure the implementation could help eliminate the risk and issue
  • Review and approve CAPA of supplier to ensure effectiveness of investigation and action plans. Raise high risk quality issue and NC trend to Supplier’s Management and ensure the implementation could help eliminate the risk and issue
  • Managing/ conducting supplier trainings.
  • Provide guidance to the regional/ local supply agreements / Non-Disclosure agreements from supplier quality standpoint.
  • Monthly Supplier Quality Performance Reporting.
  • Supporting cross regional/ cross affiliate projects
  • Provide guidance to the regional/ local supply agreements / Non-Disclosure agreements from supplier quality standpoint
  • Working with Strategic sourcing team on sourcing strategy and its implementation. 


Qualifications
  • Preferred Education: B.Tech/M. Pharm or M.Sc in Chemistry from a reputed college/university
  • Experience: Around 5 years in the Supplier Quality Management or Quality Assurance function of a Pharmaceutical Formulation/Healthcare Company.
  • In-depth knowledge of cGMP and other applicable regulations of the different regulatory authorities.
  • Working knowledge of analytical chemistry, chemical processes and Packaging Processes. Able to apply this knowledge in combination with quality system requirements to evaluate and (if applicable) to support the development of quality systems at the different suppliers.
  •  Clear, specific and concise verbal and written communication skills.
  • Ability to build up interdependent partnerships with excellent interpersonal interaction skills particularly the ability to interface with multiple Non-J&J business partners and in some instances influence without direct authority.
  • Ability to balance multiple tasks, objectives and priorities.
  • The position may require frequent travel. Incumbent may require traveling for several days in a row on outstation audits and visits.


Primary Location
Malaysia-Selangor-Petaling Jaya
Organization
Johnson & Johnson Sdn. Bhd. (8275)
Job Function
Quality Assurance
Requisition ID
1805622077W