QA Specialist, GMP & Compliance (Singapore)

Biopharma Careers; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Pfizer Asia Mfg Pte Ltd in Tuas, Singapore seeks a QA Specialist to join the quality organization. You will review and approve batch records, perform API and intermediate dispositions, and ensure adherence to Pfizer quality standards and cGMP guidelines.

The role requires a Diploma with 4+ years or a BA/BS with 1+ year in pharma QA, with strong communication and team collaboration skills. On-site position with opportunities to support regulatory activities.

Qualifications

• Diploma with 4+ years of relevant experience or BA/BS with 1+ year of relevant experience.
• Experience in the pharmaceutical industry and QA systems.
• Knowledge of current Good Manufacturing Practices (GxP).
• Strong written and oral communication skills.
• Ability to work in a team and cross-functional environment.

Responsibilities

• Review and approve master batch records and completed batch records for manufacture, packaging, and labelling of intermediates and APIs.
• Perform disposition of intermediates and APIs.
• Review and approve GMP documents, SOPs, protocols, reports, and change controls.
• Ensure compliance with cGMP, regulatory requirements, and Pfizer standards.
• Maintain quality tracking systems and metrics to identify trends.
• Support regulatory submissions and respond to queries; participate in inspections.

Skills

GxP knowledge

Teamwork

Written & verbal communication

Problem-solving

Time management

Independent work

Education

Diploma with 4+ years experience

BA/BS with 1+ year experience

Tools

ERP system

Job description

Pfizer Asia Mfg Pte Ltd in Tuas, Singapore seeks a QA Specialist to join the quality organization. You will review and approve batch records, perform API and intermediate dispositions, and ensure adherence to Pfizer quality standards and cGMP guidelines.

The role requires a Diploma with 4+ years or a BA/BS with 1+ year in pharma QA, with strong communication and team collaboration skills. On-site position with opportunities to support regulatory activities.