Senior QA Specialist: GMP Compliance & Process Excellence

Pfizer; Singapore; On-site; SGD 120,000 - 160,000; Full time

Job summary

Pfizer is seeking a Quality Assurance professional to review and approve batch records, ensure cGMP compliance, and support regulatory submissions. The role involves managing deviations, audits, and quality systems like Veeva Vault QMS and SAP.

Ideal candidates have strong problem-solving abilities, deep knowledge of GxP, and experience mentoring junior staff. On-site location in Singapore with a focus on continuous improvement and inspection readiness.

Qualifications

• Solid understanding of current Good Manufacturing Practices and relevant GxP regulations and standards.
• Strong critical thinking skills and attention to detail.
• Ability to work effectively within own team and interdepartmental teams.
• Proactive approach to problem-solving and risk management.

Responsibilities

• Review and approve master batch records and executed batch records for manufacture, packaging, and labelling of intermediates and APIs.
• Perform disposition of intermediates and APIs in compliance with Pfizer standards.
• Review and approve cleaning instructions and records to ensure compliance with global and local documents.
• Review and approve GMP documents, including SOPs, protocols, reports, and change controls.
• Ensure compliance with quality procedures, regulatory requirements, and cGMPs.
• Review deviations and coordinate investigations including root-cause analyses and CAPAs.

Skills

Critical thinking

Team collaboration

Problem solving

Proactive approach

Education

Diploma with 8+ years experience

Associate's degree with 6+ years

BA/BS with 4+ years

Tools

Veeva Vault QMS

SAP

Job description

Pfizer is seeking a Quality Assurance professional to review and approve batch records, ensure cGMP compliance, and support regulatory submissions. The role involves managing deviations, audits, and quality systems like Veeva Vault QMS and SAP.

Ideal candidates have strong problem-solving abilities, deep knowledge of GxP, and experience mentoring junior staff. On-site location in Singapore with a focus on continuous improvement and inspection readiness.