Johnson & Johnson Careers

Senior Engineer-External Manufacturing Quality

Chiyoda, Japan
Quality Assurance

Job Description

Requisition ID: 1805673810W

  • Responsible for assigned Japan EM (External manufacturer) product quality and release operation.
  • Support execution of new/current EM GMP qualification regular audit/assessment from external and internal parties and AAP (Audit Action Plan) follow-ups.
  • Lead Quality meetings with EM management team
  • Execute GMP/Quality improvement initiatives at EM sites (e.g., Zero Defect Program, Mix-up prevention, Micro design robustness etc.,)
  • Ensure that every EM has established and effectively maintained quality management system and quality practices that meet J&J requirements.
  • Review and periodically monitor manufacturing processes at EM site for improvements and compliance enhancement.
  • Co-ordinate the investigation of non-conformance, evaluate casual drivers and determine CAPA actions. Participate in final investigation decision for non-conforming materials/products.
  • Support complaint handling investigation process and timely response in co-ordination with EM.
  • Conduct GMP audit and Microbial risk assessment at EM sites
  • Represent EM QA in NPI (New product introduction) cross-functional team. Ensure flawless execution of new product launches.
  • Review specifications for new products/processes and RM/PM specifications.
  • Participate in development of protocols and shop-floor execution of process qualification, C&S validations and APR (Authorization of product release) for new/modified products.

  • Education Requirement::Bachelor or Master of Science/ Pharmaceutical Degree, preferably Chemistry, Pharmaceutical or Biological Science.
  • Minimum Experience: Six to Nine years of QA related work experience of cosmetic/pharmaceutical manufacturing,
  • Knowledge of Microbiology in Cosmetic/Pharmaceutical quality assurance
  • Additional experience in Engineering/Technical and /or Operations is preferred.
  • Exposure to regulators audits and regulatory requirements. 

Primary Location
Johnson & Johnson K.K. (8235)
Job Function
Quality Assurance
Requisition ID