Johnson & Johnson Careers

Senior Business Quality Specialist

Beijing, China
Quality Control


Job Description

Requisition ID: 1905735525W

Overall purpose of job:

The (Sr.) Business Quality Specialist supports the Business Quality Head/QE, to ensure the quality of, and meeting the applicable requirements for, the products that Xian Janssen markets and quality system maintenance.
 
He/she has a supporting role to ensure compliance with the local laws/regulations and the elements of the Johnson & Johnson Quality Policy that are applicable to the GxP activities Xian Janssen undertakes. In this role he/she supports the BQ Head/QE with the implementation and maintenance of the quality system & processes as are described in the Business Quality Manual and is dedicated to continuous improvement thereof.
 
Essential duties and responsibilities:
  • Quality System Elements
    • Quality System:
      • Support maintenance and implementation of the Quality System as are described in the Business Quality Manual (BQM).
      • Help to monitor quality system performance versus local GxP, BQM and J&J requirements via use of pertinent business and compliance metrics and goals.
      • Support activities related to continuous improvement of the Quality System using quality system performance information, in conjunction with information from periodic internal audits, deviation management, CAPA management etc.
    • Regulatory Compliance:
      • Support maintenance and proper filing/archiving of up to date list of all relevant product licences (marketing authorizations)  and Technical Agreements per BQM
      • Support activities to ensure that Xian Janssen products, packaging components, labelling meet the local regulatory requirements
    • Training and qualification: Support activities to prepare, update, train and implement global BQ/local LOC procedures in accordance with local GxP, BQM and J&J requirements.
    • Document, data and Change Controls:
      • Support execution of minimum requirements regarding lifecycle management of GxP related documents and records (creation, approval, distribution, revision, retrieval, retention, and disposition) to ensure regulatory compliance and business continuity.
    • Inspection Management: Support the preparation, execution and follow up for external inspections.
    • Escalation of Quality and Regulatory Compliance issues:
      • Support LOC Head of Business Quality and other affected stakeholders with any substantive concerns regarding product quality, safety and/or compliance, as per the Escalation procedures outlined in BQM

Qualifications
The (Sr.) Business Quality Specialist  should meet the following knowledge, experience and skills:
•      Bachelor’s degree or higher in Chemistry / Pharmacy / Microbiology / Medicine or a related scientific discipline;
•      2- 5 years’ experience in the Pharmaceutical or related industry, ideally with a mix of Quality and Compliance (GxP), Distribution Warehouse management, Regulatory Affairs and some Sales & Marketing experiences. Quality and Compliance experience is essential;
•      Understanding of pharmaceutical product development, qualification, manufacturing, packaging, validation, testing, release and distribution processes;
•      Up-to-date knowledge of relevant pharmaceutical legislation and GxP;
•      Knowledge and full understanding of the J&J Quality Policy (POL 001), and the procedures and processes outlined in this Manual;

•      Full competency in local language and a working knowledge of English

•      Good command in English both in writing and verbally


Primary Location
China-Beijing-Beijing-
Organization
Xian-Janssen Pharmaceutical Ltd. (7043)
Job Function
Quality Control
Requisition ID
1905735525W