Specialist Quality Assurance (Disposition/Batch Release)

About the role

Amgen Singapore Manufacturing (ASM) is looking for a Specialist Quality Assurance (Disposition) to provide oversight of lot disposition activities within the Quality organization. The role covers incoming and product disposition, post-disposition issues, QA oversight for Supply Chain and leadership of Quality Assurance initiatives.

Key responsibilities

• Act as disposition SME reviewer for site and network change controls and represent the site as SME for the global disposition network
• Serve as SME for SAP ERP quality transactions
• Review routine GMP documentation such as SOPs, logbooks, work orders, batch production reports, electronic batch records and validation protocols
• Manage deviations and root cause investigations, and author and maintain inspection playbooks
• Take part in regulatory inspections and audits and liaise directly with inspectors and auditors
• Lead and support QA/OE continuous improvement and manage quality performance metrics for disposition
• Escalate significant quality, compliance, supply and safety issues to Quality management
• Mentor and coach team members, and act as trainer for disposition processes

Required profile

• Doctorate, or Master's degree with 2 years of experience in a pharmaceutical company or GMP environment, or Bachelor's degree with 4 years of experience, or Diploma with 8 years of experience
• Demonstrated experience in manufacturing, process development or quality assurance in the pharmaceutical industry, with project management, quality assurance and quality systems experience
• Good technical writing and verbal communication skills
• Able to work independently, manage multiple activities and collaborate with diverse teams

Selectees must meet the medical requirements of the role; the company bears the cost of any required medical checks.