Company And Job Overview
Our client specializes in manufacturing and selling medicinal and pharmaceutical products. As part of their expansion, they are now seeking a QA/QM Associate to manage QA/QM activities for Malaysia and Singapore.
Job Responsibilities
- Oversees quality documentation, including drafting/revising SOPs and maintaining compliant quality records and document control systems
- Administers training programs, manages the elearning system, and delivers GDP onboarding and refresher sessions
- Manages quality systems, including change control, deviations, complaints, returned goods, CAPA tracking, PQR coordination, and annual quality reviews
- Ensures regulatory and GDP compliance, supporting inspections, managing product release/redressing compliance, and conducting mock recalls
- Oversees vendor quality, including qualification, performance tracking, issue resolution, and support for vendor audits
- Collaborates crossfunctionally and supports regional/global quality initiatives to ensure compliant operations across the business
Job Requirements
- Bachelor's degree in Pharmacy, Life Sciences, or related discipline
- Possesses 13 years of experience in pharmaceutical QA
- Has a solid grasp of GDP, GMP, PIC/S, ICH standards, as well as local NPRA regulations
- Able to interpret global SOPs and tailor them to meet local regulatory requirements
- Shows strong analytical and problemsolving capabilities, particularly in understanding complex regulatory frameworks
- Exhibits excellent organizational skills and effective process management
- Adaptable and able to perform well in a fastchanging regulatory environment
- Displays a strong sense of ownership and works independently with minimal supervision
- Brings strong teamwork and stakeholder management skills, collaborating effectively with regulatory, supply chain, commercial, and regional/global QA teams
Interested applicants, feel free to click APPLY NOW.
