Senior QA Specialist – Lead GMP Quality & Compliance

Pfizer; Johor; On-site; MYR 120,000 - 180,000; Full time

Job summary

Pfizer Malaysia seeks an experienced Quality Assurance professional to ensure GMP and GxP compliance across manufacturing, packaging and labelling activities. The role focuses on batch record reviews, API disposition, and control of GMP documentation within a validated quality system.

You'll contribute to regulatory readiness, drive improvements, mentor junior colleagues, and support internal audits and external inspections as part of Pfizer's commitment to patient safety and product quality.

Qualifications

• Diploma with 8+ years of relevant experience, or Associate with 6+ years, or BA/BS with 4+ years.
• Solid understanding of GMP and GxP regulations.
• Strong critical thinking skills.
• Ability to work effectively within own team and interdepartmental teams.
• Proactive approach to problem-solving.

Responsibilities

• Review and approve master batch records and executed batch records for manufacturing, packaging and labelling.
• Perform disposition of intermediates and APIs.
• Review and approve GMP documents, including SOPs, protocols, reports, and change controls.
• Maintain quality systems, support regulatory submissions and inspections.
• Escalate issues per Pfizer guidelines and mentor junior QA staff.

Skills

Critical thinking

Teamwork

Problem solving

Attention to detail

Education

Diploma / 8+ yrs

Associate degree / 6+ yrs

BA/BS / 4+ yrs

Tools

Veeva Vault QMS

SAP

Job description

Pfizer Malaysia seeks an experienced Quality Assurance professional to ensure GMP and GxP compliance across manufacturing, packaging and labelling activities. The role focuses on batch record reviews, API disposition, and control of GMP documentation within a validated quality system.

You'll contribute to regulatory readiness, drive improvements, mentor junior colleagues, and support internal audits and external inspections as part of Pfizer's commitment to patient safety and product quality.