Johnson & Johnson Careers
Senior Engineer-External Manufacturing Quality
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.
Johnson & Johnson K.K. (8235)