Specialist Quality Assurance (Deposition/Batch Release)

Amgen; Singapore; On-site; SGD 90,000 - 140,000; Full time

Job summary

Amgen Singapore seeks a Specialist Quality Assurance I (Disposition) to serve as disposition SME for site and network change controls and act as SME for SAP ERP Quality Transactions. The role covers supporting GMP documentation, deviations, inspections, and continuous improvement initiatives across the disposition function.

The ideal candidate has doctoral or advanced degrees with corresponding GMP/pharma experience, strong communication, and ability to manage multiple activities in a dynamic

Qualifications

• Doctorate Degree
• Master’s degree and 2 years of experience in pharmaceutical company or GMP environment OR
• Bachelor’s degree and 4 years of experience in pharmaceutical company or GMP environment OR
• Diploma and 8 years of experience in pharmaceutical company or GMP environment
• Good communication skills (technical writing and verbal communication/presentation)
• Demonstrated related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical industry with progressively increasing responsibility and demonstrated experience in project management, quality assurance, and quality systems.
• Interact effectively with variety of communication and working styles and ability to work well in teams
• Ability to manage multiple simultaneous activities in a rapidly changing environment
• Ability to work independently with minimal supervision
• Ability to build strong and collaborative partnerships with client groups and influence changes in practices to ensure compliant manufacturing

Responsibilities

• Participate as disposition SME review for site and network change controls
• Represent as site Subject Matter Expert (SME) for Disposition process in the global disposition network
• Serve as SME for SAP ERP Quality Transactions
• Support routine GMP documentation and review activities (e.g. SOPs, logbooks, work orders, batch production reports, electronic batch records, and validation protocols etc.)
• Participate in and manage deviations and root cause investigations
• Author and maintain inspection playbooks and drive inspection readiness efforts
• Participate in regulatory inspections / audits and interact directly with regulatory inspectors / auditors
• Lead and support site/network driven QA/OE continuous improvement initiatives
• Manage quality performance metrics for disposition
• Escalate significant quality, compliance, supply and safety issues to Quality management in a timely manner
• Mentor and coach team members in order to establish a quality culture for routine operations
• Serve as Trainer for disposition processes
• May act as delegate to Disposition function lead to support business needs

Skills

Quality Assurance

Project Management

Technical Writing

Verbal Communication

Team Collaboration

Critical Thinking

QA Documentation

Education

Doctorate Degree

Master’s Degree

Bachelor’s Degree

Diploma

Tools

SAP ERP

Quality Management System

Job description

Join Amgen’s Mission to Serve Patients

At Amgen, our shared mission to serve patients living with serious illnesses drives everything we do. Every team member plays an important role in helping advance science and deliver medicines that make a meaningful difference for patients around the world.

Amgen fights the world’s toughest diseases by harnessing the best of biology and technology. We draw on our scientific expertise to push beyond what is known today and help people live longer, fuller lives.

If you are energized by collaboration, continuous learning, and meaningful work, we invite you to join our team and help make an impact.

Specialist Quality Assurance I (Disposition)

What you will do

• Participate as disposition SME review for site and network change controls
• Represent as site Subject Matter Expert (SME) for Disposition process in the global disposition network
• Serve as SME for SAP ERP Quality Transactions
• Support routine GMP documentation and review activities (e.g. SOPs, logbooks, work orders, batch production reports, electronic batch records, and validation protocols etc.)
• Participate in and manage deviations and root cause investigations
• Author and maintain inspection playbooks and drive inspection readiness efforts
• Participate in regulatory inspections / audits and interact directly with regulatory inspectors / auditors
• Lead and support site/network driven QA/OE continuous improvement initiatives
• Manage quality performance metrics for disposition
• Escalate significant quality, compliance, supply and safety issues to Quality management in a timely manner
• Mentor and coach team members in order to establish a quality culture for routine operations
• Serve as Trainer for disposition processes
• May act as delegate to Disposition function lead to support business needs

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodation for additional tasks and responsibilities.

What we expect of you

• Doctorate Degree
• Master’s degree and 2 years of experience in pharmaceutical company or GMP environment OR
• Bachelor’s degree and 4 years of experience in pharmaceutical company or GMP environment OR
• Diploma and 8 years of experience in pharmaceutical company or GMP environment
• Good communication skills (technical writing and verbal communication/presentation)
• Demonstrated related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical industry with progressively increasing responsibility and demonstrated experience in project management, quality assurance, and quality systems.
• Interact effectively with variety of communication and working styles and ability to work well in teams
• Ability to manage multiple simultaneous activities in a rapidly changing environment
• Ability to work independently with minimal supervision
• Ability to build strong and collaborative partnerships with client groups and influence changes in practices to ensure compliant manufacturing

What you can expect of us

As we work to develop medicines for patients, we also invest in our people. Through competitive benefits, development opportunities, and a collaborative culture, we’ll support your growth both professionally and personally.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values as we continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity Employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.