Quality Compliance Specialist

TAKEDA MANUFACTURING SINGAPORE PTE. LTD.

Woodlands, Singapore
3-5 years pharmaceutical manufacturing experience
Knowledge of eudralex, 21 cfr, ich regulations
Lead auditor capabilities for self-inspections
This position is responsible for site quality compliance governance and product quality communications to achieve Takeda Singapore's objectives

Job Summary

  • This position is responsible for site quality compliance governance and product quality communications to achieve Takeda Singapore's objectives.
  • The role involves leading the self-inspection program, managing regulatory inspections, and overseeing supplier qualification audits.
  • Takeda offers a stimulating career in a patient-focused company committed to delivering better health through life-changing work.

Matching Summary

This position is responsible for site quality compliance governance and product quality communications to achieve Takeda Singapore's objectives.

Skills & Requirements

Must-have

  • 3-5 years pharmaceutical manufacturing experience
  • Knowledge of Eudralex, 21 CFR, ICH regulations
  • Lead auditor capabilities for self-inspections
  • Supplier qualification and audit execution
  • Cross-functional collaboration skills

Nice-to-have

  • Diplomatic communication with diverse personalities
  • Experience presenting to senior management
  • Ability to mediate common understanding on compliance
  • Logical problem-solving for timely solutions

Key Requirements

  • University degree in Biotechnology, Chemistry, Pharmacy, Science, or Engineering
  • Minimum 3-5 years experience in Pharmaceutical manufacturing
  • Substantial knowledge of regulatory requirements like Eudralex and 21 CFR

Work Rights

Not specified

Tailored Resume

Cover Letter