Associate Manager/ Manager, Quality Assurance

Elvium

Singapore, Singapore
Gxp and gdp regulatory compliance
Quality management system implementation
Product release decision making authority
The role is accountable for establishing and maintaining a Quality Management System that complies with GxP requirements including GDP and GMP

Job Summary

  • The role is accountable for establishing and maintaining a Quality Management System that complies with GxP requirements including GDP and GMP.
  • Responsibilities include ensuring all product handling, distribution, and storage adhere to local regulatory standards and Mundipharma regulations.
  • The position requires managing the full lifecycle of quality documentation, complaints, recalls, and internal audit programs.

Matching Summary

The role is accountable for establishing and maintaining a Quality Management System that complies with GxP requirements including GDP and GMP.

Skills & Requirements

Must-have

  • GxP and GDP regulatory compliance
  • Quality Management System implementation
  • Product release decision making authority
  • Supplier and customer auditing
  • CAPA and deviation investigation

Nice-to-have

  • Trend analysis in industry standards
  • Emergency and safety planning
  • Controlled drugs security procedures
  • Rapid alerts management process

Key Requirements

  • Degree in Pharmacy, Chemistry or related discipline
  • Registered Pharmacist status preferred
  • Minimum 5 years experience in GxP/GDP
  • Minimum 3 years operational management of QMS
  • Trained internal auditor for GMP/GDP

Work Rights

Not specified

Tailored Resume

Cover Letter