Specialist Quality Assurance (Technical Support)

Amgen; Singapore; On-site; SGD 75,000 - 110,000; Full time

Job summary

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

Qualifications

• 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

Responsibilities

• 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.

Skills

Quality oversight

GMP compliance

Regulatory inspections

Root cause analysis

Project management

Education

PhD or Master’s in related field

Bachelor’s degree in related field

Diploma in related field

Job description

Career Category Quality 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

Main Responsibilities

• Provide quality oversight to plant operations, ensuring appropriate application and execution of GMP compliance requirements and Amgen Quality Management System in plant operations through phases of commissioning and qualification, regulatory approval and market supply
• Support routine GMP documentation review activities (e.g. SOPs, logbooks, work orders, validation documents, periodic reviews) and ensure key performance indicator met targeted metrics
• Co-lead and support the deployment of Amgen quality systems, including management review, validation, deviation, change control and CAPA and ensure that the systems are managed in compliance with cGMP expectations
• Review and approve deviations, investigations, testing result investigations, change controls, and other quality records (with focus on highly complex records)
• Participate in and lead complex root cause investigations for deviations
• Lead Quality Assurance oversight in commissioning and qualification projects or New Product Introduction (NPI)
• Coach site Quality Assurance professionals on resolution of quality issues
• Participate in regulatory inspections and interact directly with regulatory inspectors
• Lead or support function/site/network initiatives and continuous improvement projects

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

Preferred 8 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical / biologics industry with progressively increasing responsibility and demonstrated experience in project management, quality assurance, and quality systems.

Direct experience with bulk manufacturing of biopharmaceuticals/API preferred.

Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff. People and stakeholder management.

Experience with regulatory audits and inspections· Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality.

Your selection for this role will be subject to fulfilling the medical requirements of this job scope. If so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company.

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 . Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen