Job title: QMS Specialist (Quality System) - US MNC / Medical Devices / $5k+AWS+VB (SPVNP)
Job type: Permanent
Emp type: Full-time
Location: Singapore
Job published: 05 Apr 2021
Job ID: 34445
Contact name: Vickus Ng
Phone number: 6595 0627

Job Description

Career opportunity in a leading manufacturer of Packaging Components & Delivery Systems for injectable drugs & healthcare products:
  • Basic up to $5,000 + AWS + VB
  • US MNC career opportunity
  • Permanent opportunity
Working Hours: Monday to Friday (8:00 am to 5:00 pm)
Working Location: Joon Koon (Company transport provided)
 
Responsibilities:
  • Support the global/regional China DMF-related activities from pre-registration until post-registration.
  • Writing technical reports as required to support China DMF submissions.
  • Writing / updating existing QA documents related to China DMF project.
  • Support necessary initiatives to continuously improve on the workflow and systems.
  • Being a Subject matter expertise on quality systems and requirements.
    • Provide input to and ensure consistency of the Technology Transfer documents from project initiation until completion of transfers.
    • Analyze contents of the Tech Transfer documents, ensure critical quality attributes (CQAs) are challenged to prove product equivalency and mitigate identified risk.
    • Work with Tech Transfer team to prepare Risk Assessment and Risk Mitigation documents for approval.
    • Support customer notification and summary reports related to Technology Transfer.
  • Implement and maintain the effectiveness of quality systems for the AP region.
  • Set up a quality audit system to assess conformance to specifications, company procedures and customer requirements for the Asia Pacific plants.
  • Other duties as assigned by manager.
Requirements:
  • min. Diploma / Degree in any relevant Science discipline.
  • Experinece in oharmaceutical / medical devices environment
  • Knowledge in ISO 9001 / ISO 15378
 
To apply, please send your updated resume to spvn@scientecpersonnel.com.
 
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We will contact you if your skills and experience are suitable for the role, or if there is a similar opportunity that is available presently or in the future.
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ScienTec Consulting Pte Ltd | 11C5781