Biopharma QA Specialist: GMP & NPI Oversight

Amgen; Singapore; Presencial; SGD 75.000 - 110.000; Jornada completa

Descripción de la vacante

Amgen Singapore invites applications for Specialist Quality Assurance I. The role oversees GMP compliance, adherence to the Amgen Quality Management System, and QA activities through commissioning, qualification, and market supply.

You will review documentation, lead CAPA and change controls, and participate in regulatory inspections. The ideal candidate has advanced degrees with pharma/GMP experience and strong root cause analyses, project management, and communication skills to support quality

Formación

• Doctorate Degree Master’s degree with 2+ years in pharma/GMP or Bachelor’s with 4+ years in pharma/GMP or Diploma with 8+ years in pharma/GMP

Responsabilidades

• Provide quality oversight to plant operations ensuring GMP compliance and QMS in commissioning and qualification, regulatory approval and market supply.
• Review GMP documentation (SOPs, logbooks, work orders, validation documents, periodic reviews) ensuring KPIs are met.
• Co-lead and deploy Amgen quality systems including management review, validation, deviation, change control and CAPA in compliance with cGMP.
• Review and approve deviations, investigations, testing result investigations, change controls and other quality records.
• Participate in and lead complex root cause investigations for deviations.
• Lead QA oversight in commissioning/qualification projects or New Product Introduction (NPI).
• Coach site QA professionals on resolution of quality issues and participate in regulatory inspections.

Conocimientos

Quality oversight

GMP compliance

Regulatory inspections

Root cause analysis

Project management

Educación

PhD or Master’s in related field

Bachelor’s degree in related field

Diploma in related field

Descripción del empleo

Amgen Singapore invites applications for Specialist Quality Assurance I. The role oversees GMP compliance, adherence to the Amgen Quality Management System, and QA activities through commissioning, qualification, and market supply.

You will review documentation, lead CAPA and change controls, and participate in regulatory inspections. The ideal candidate has advanced degrees with pharma/GMP experience and strong root cause analyses, project management, and communication skills to support quality