GMP QA Manager

1 week ago


Singapore DAIICHI SANKYO SINGAPORE PTE. LTD. Full time
Roles & Responsibilities

Job Objectives

  • Establish DSSG Quality Management System (QMS) in GMP QA through review and improvement of operational process, and ready for obtaining the importation license and new product launch.
  • Promote GMP/GDP QA activities and enhance QMS. As a result, contributed to the stable supply of the highest quality products and DS's business success.
  • Assist in assuring the quality of products allying with each local QA in Asia.
  • Enhance Global QA management and activities (Global SOP, QMS, Fostering Quality Culture, Training, Corporate GMP Audit etc.)

Job Responsibilities:

  • Support Head of GMP-QA Office, and report QA activities to the head of GMP-QA.
  • Perform QA for Imported Finished Products and CMO / Logistics management (Review QC report & Product release, Deviation, Change control, Complaint, Product Recall, Return, Improve quality issues, Maintain QA agreement, Enhance DI), GMP/GDP audit, appropriate document management including SOP.
  • Market delivery release
  • Enhance DSSG QMS allying with DSG company regionally / globally
  • Contact with Authority if necessary
  • Support DS group company activities
  • Contribute to enhance Global QA management and activities (Global SOP, QMS, Fostering Quality Culture, Training, Corporate GMP Audit etc.)

Job Specification:

Technical Skills

  • B. degree or higher in Pharmaceutical or related science categories
  • Language: English and Chinese or Japanese
  • GMP-QA Management including product release (5 years)
  • QMS (Quality Management System) Management / experience of operating eQMS is preferable
  • Bio knowledge preferred (to prepare for further ADC)
  • General PC operation (Word, Excel, PPT preparation)

Soft Skills

  • Logical Problem-solving
  • Decision making
  • Communication
  • Leadership,
  • Collaboration and Teamwork,
  • Adaptability,
  • Time management,
Tell employers what skills you have

Document Management
Leadership
Quality Management
Quality Assurance
ISO
GMP
Logistics Management
Soft Skills
Adaptability
Time Management
Change Control
Decision Making
Audit
Japanese
Product Launch
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