Johnson & Johnson Careers

[Medical Devices] - Senior Quality Assurance Analyst

Mongkok, China
Quality Assurance


Job Description

Requisition ID: 1905726835W

Overall purpose of job: 

The position is designed to ensure the implementation of Quality System Compliance within the scope of DELIVER activities in HK and supporting as well Regional DELIVER Q&C Strategies on the quality and compliance execution, through:

  • Implementing and evaluating a highly effective Quality & Compliance Function and Awareness within DELIVER Hong Kong Community – cross sectors(Medical Device, Consumer segment and Surgical Vision(partially) in Hong Kong)
  • Independently partnering with HK business quality, Regional DELIVER, JNJ Third Party quality and operational leader as well as another affiliate for DELIVER Q&C.
  • Close collaboration with business quality, local regulatory team, Supply Chain, and JNJ Third Party Logistics/Supplier.

Essential duties and responsibilities:

  • Ensuring HK DC under scope of DELIVER meets all appropriate related requirement such as: regulatory authority, and sector requirements.
  • Support and maintain regional DELIVER Q&C Dashboard as per agreed target
  • Implement and support Quality System implementation within the scope of DELIVER, includes ensuring HK sites meet DELIVER DC QSCAN, GWP requirements and conducting internal audit to JNJ Third Party Logistics/Supplier. as well as ensure satisfactory closure of JJRC AAP of JNJ Third Party Logistics/Supplier.
  • Support CIP program related to DELIVER Q&C at HK.
  • Ensure compliance of HK sites to the Global and Regional Guidelines and Policies including enterprise standards related to Quality and Regulatory Compliance for DELIVER.
  • Established quality agreement at all HK JNJ Third Party Logistics/Supplier for warehousing, transportation and other 3rd party services related.
  • Flawless execution on global standard requirement for repack/relabel facilities at HK under scope of DELIVER.
  • Ensure timely JNJ DC quality reviews are conducted and actively participate on management review of site business quality
  • Support an appropriate and timely closure of related to quality and compliance customer complaint at JNJ Third Party Logistics/Supplier of TW/HK.
  • Maintain and monitor system compliance such as for NC/CAPA, training program, change.
  • Partners with DELIVER Operations to implement business solutions and leads compliance efforts associated with complex projects and activities through effective implementation of the Audit Action Plan (AAP) process
  • Supplier Audit program and ensure inspection readiness and provide strategic focus for quality and compliance by working with appropriate functional areas to identify continuous improvement opportunities
  • Coordinates and reports timely and accurate metrics and analysis per J&J policies. Reporting responsibilities within HK include (but are not limited to):  Metric evaluation and reporting in CURVE entry updates.
  • Accountable for Quality management of repacking, relabeling, over labeling, kitting, and reworking operations conducted within the DC
  • Accountable for accurate and timely communication of temperature control excursions occurring within the DC to appropriate partner
  • Accountable for the investigation of temperature control excursions and subsequent remediation activities
  • Accountable for overseeing the controls and quality standards for all distribution

  • Qualifications

    Requirements

    • More than 5-year experience in QC or QA Function of any Medical devices or Pharmaceuticals Industry
    • Bachelor’s Degree in science (Life Sciences, Microbiology, etc.) or Engineering required.
    • Good knowledge of Good Distribution Practices (GDP), GMP and validation- demonstrated knowledge and application of QSR, ISO9001, ISO13485 and other international standards.
    • Certified Auditor of GMP, ISO 9001, or ISO 13845.
    • Knowledge of manufacturing environment or repackaging/relabeling environment
    • Fluency in English language required.

    Essential knowledge and skills:


    • Good knowledge of Good Distribution Practices (GDP), GMP and validation- demonstrated knowledge and application of QSR, ISO9001, ISO13485 and other international standards.
    • Certified Auditor of GMP, ISO 9001, or ISO 13845.
    • Knowledge of manufacturing environment or repackaging/relabeling environment
    • Fluency in English language required.
    • Demonstrated knowledge and experience in quality or operations function.
    • Task oriented with proven experience in the delivery high quality work
    • Proficiency in Microsoft Office (PowerPoint) other tools required to develop training materials
    • Excellent analyzing / decision making ability

    Personal data provided by job applicants will be used for recruitment purpose only.Candidates who are not being invited for interviews within four weeks may consider their applications unsuccessful. All applications will be kept for maximum of six months as future reference for similar openings.


    Primary Location
    China-Hong Kong S.A.R.-Mongkok-
    Organization
    Johnson & Johnson (Hong Kong) Ltd. (8060)
    Job Function
    Quality Assurance
    Requisition ID
    1905726835W