Pharma QA Specialist: GMP Impact, Onsite

Pfizer Pte Ltd; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Pfizer is seeking a Quality Assurance professional to review and approve master batch records, completed batch records, and related documentation for manufacture, packaging and labeling of intermediates and APIs. You will ensure compliance with Pfizer quality standards and registered regulatory specifications.

You will conduct disposition of intermediates and APIs, review GMP documents and change controls, maintain quality tracking systems, support regulatory submissions, and participate in

Qualifications

• Diploma with at least 4 years of relevant experience or BA/BS with at least 1 year of relevant experience.
• Experience in the pharmaceutical industry and Quality administered systems.
• Sound knowledge of current Good Manufacturing Practices (part of GxP).
• Ability to work effectively in a team environment, both within one's own team and interdepartmental teams.
• Effective written and oral communication skills.

Responsibilities

• Review and approve master batch records and completed batch records for the manufacture, packaging, and labelling of intermediates and active pharmaceutical ingredients (APIs), ensuring compliance with Pfizer quality standards and registered regulatory specifications.
• Perform disposition of intermediates and active pharmaceutical ingredients (APIs).
• Review and approve GMP documents, including SOPs, protocols, reports, and change controls, for compliance with Pfizer Global and Local Document Standards.
• Ensure compliance with quality procedures, regulatory requirements, and current Good Manufacturing Practices (cGMP).
• Review and approve deviations in accordance with site procedures, including investigation reports, root cause analyses, corrective and preventive actions, and quality, validation, stability, and regulatory impact assessments conducted with subject matter experts.
• Maintain quality tracking systems and metrics to proactively identify trends and atypical observations.
• Support preparation of Annual Product Records, evaluate trends and atypical observations, and recommend improvement actions.
• Maintain inspection readiness and support regulatory and customer inspections. Participate actively in GMP walkdowns to keep site operations and facilities inspection-ready.
• Support maintenance of the validated state of GMP systems and processes.
• Support regulatory submissions and respond to regulatory queries promptly.

Skills

Quality Assurance

GxP knowledge

Communication skills

Teamwork

Education

Diploma or BA/BS in relevant field

Job description

Pfizer is seeking a Quality Assurance professional to review and approve master batch records, completed batch records, and related documentation for manufacture, packaging and labeling of intermediates and APIs. You will ensure compliance with Pfizer quality standards and registered regulatory specifications.

You will conduct disposition of intermediates and APIs, review GMP documents and change controls, maintain quality tracking systems, support regulatory submissions, and participate in