Johnson & Johnson Careers

Senior Engineer-External Manufacturing Quality

Sydney, Australia
Quality Assurance

Job Description

Requisition ID: 1805682470W

  • Based at Ultimo, NSW
  • Great opportunity to join a global brand
Be vital to this role
Reporting to the Site Lead- External Manufacturing Quality, you will be responsible for assigned Pacific EMs (External manufacturer) product quality and release operation.
This role will Responsible for assigned Pacific EMs (External manufacturer) product quality and release operation whilst also supporting the execution of new/current EM GMP qualification regular audit/assessment.
Some of the key responsibilities will include:
  • Lead Quality meetings with EM management team
  • Execute GMP/Quality improvement initiatives at EM sites (e.g., Supplier Quality Excellence 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
Be valued for who you are
For you to be successful in the role you will need:
 Education Requirement:
  • Bachelor or Master of Science/ Pharmaceutical Degree, preferably Chemistry, Pharmaceutical or Biological Science.
  • Minimum Experience: Minimum 5 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.
     Be part of something bigger than yourself in the Johnson & Johnson Family of Companies
    Caring for the world one person at a time has inspired and united the people of Johnson & Johnson for 125 years. We embrace research and science bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day throughout the world.
    Please apply online using the link above. You will receive an automated email confirming receipt of your application. Every application is reviewed by the Talent Acquisition team and candidates will receive notification of the outcome of their application in a timely manner.
    Applications Close:  25th September 2018. 

Primary Location
Australia-New South Wales-Sydney
Johnson & Johnson Pacific Pty. Ltd. (7470)
Job Function
Quality Assurance
Requisition ID