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Business Quality Specialist

Keywords / Skills : Business Quality Specialist

Posted: 2018-11-05

Sales/ Business Development
Other Roles
Posted On
5th Nov 2018
Job Ref code
Job Description

Company Description 
Our client is an US healthcare company with a broadly diversified business across consumer, pharmaceutical and medical device segments. They have an annual turnover of US$70 billion, with more than 125,000 employees across 60 countries with a heritage of more than 130 years.​ 

Duties and Responsibilities
This role is responsible to support the execution of Quality activities related to incoming inspection for the Pharmaceuticals sector and review the complaint and adverse event records for the Medical Devices sector.

This role also supports the Non-Conformances (NC), Corrective Action and Preventive Action (CAPAs), Change Controls and Work Instructions, especially on temperature excursion and repack/relabel for Pharmaceuticals and Medical Devices sector.

In addition, this role supports the site audit readiness in training administration and document management.
  • Sales & Marketing Support (Pharm)
    • Support the review of incoming inspections and temperature data monitoring for Pharm products
    • Support the creation and investigation of NCs/CAPAs and monitors the trend and complete the investigation timely for the NCs/CAPAs related to temperature excursion
  • Sales & Marketing Support (Medical Devices)
    • Support in the creation of Work Instructions for repack/relabel for Medical Device products.
    • Support the review and closure of complaint and adverse event records from CRM System
  • Audit Readiness
    • Support training administration process for LOC
    • Support document management quality system for LOC
    • Ensure compliance and audit-readiness to J&J Quality Policy Standards and applicable procedures.
  • Support the Singapore local operating company in tracking and monitoring of Non- Conformances, CAPAs, Change Controls and Audit Actions as per timelines for Consumer, Medical Devices and Pharmaceutical sectors.
  • Coordinates key quality metrics reporting. This includes Non-Conformances, CAPAs, Complaints, Change Control and Audit Actions tracking and monitoring as per timelines.
  • Understand and ensure continued compliance to global and local regulatory requirements with respect to assigned responsibilities.

  • Bachelor's degree or equivalent in Science, Pharmacy or related discipline with 1-2 years of experience in business quality.
  • Familiarity with current Good Manufacturing Practice, the regulatory systems and product registration requirements in Singapore
  • Must be able to develop and maintain excellent working relationships, work successfully within a team environment and as an individual contributor
  • Proactive team player, able to take charge and follow-through. 
  • Proficiency in Microsoft applications such as Excel, Word, PowerPoint. 

On top of a competitive base salary, the company offers excellent career and training opportunities, attractive benefits and bonus schemes. If you are keen to take your career on to the next level, click apply. 
EA License: 94C3609 
Reg No: R1655737

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