QA Senior Specialist (Disposition)

WUXI XDC SINGAPORE PRIVATE LIMITED

Singapore
Not specified (considered on-site based on job functions)
Gmp manufacturing batch record review
Material qualification activities management
Batch approval or rejection based on specs
WUXI XDC Singapore is seeking a QA Senior Specialist (Disposition) to oversee the compliance and timely disposition of GMP materials and products. The ideal candidate will have significant QA experience in the biopharma industry and will be responsible for ensuring quality standards are met through collaboration with various teams

Job Summary

  • The role is responsible for overseeing the timely and compliant disposition of GMP materials and products while ensuring adherence to critical quality attributes.
  • Candidates will collaborate with Procurement, QC, Warehouse, and Manufacturing teams to maintain qualified supplier status and resolve discrepancies prior to disposition.
  • The position requires managing quality events such as deviations, change controls, CAPAs, and lab investigations while supporting internal and external audits.

Matching Summary

Match Score: 85

WUXI XDC Singapore is seeking a QA Senior Specialist (Disposition) to oversee the compliance and timely disposition of GMP materials and products. The ideal candidate will have significant QA experience in the biopharma industry and will be responsible for ensuring quality standards are met through collaboration with various teams.

Skills & Requirements

Must-have

  • GMP manufacturing batch record review
  • Material qualification activities management
  • Batch approval or rejection based on specs
  • Deviation and CAPA resolution
  • Internal and external audit support

Nice-to-have

  • New site start-up experience preferred
  • ADC manufacturing knowledge is a plus
  • Strong logical thinking abilities
  • Excellent cross-functional collaboration skills
  • Demonstrates strong ownership mentality

Key Requirements

  • Bachelor's degree in Biologics, Pharmacy, or related field
  • 5-10 years of relevant QA experience in Biopharma
  • Familiarity with FDA, EMEA, and PICS GMP requirements
  • Proficiency in English communication skills
  • Experience with Lot Disposition preferred

Work Rights

Not specified

Tailored Resume

Cover Letter