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Specialist Quality Assurance

2 weeks ago

Singapore Amgen Full time

**Specialist Quality Assurance I**

**Amgen Singapore Manufacturing**

**HOW MIGHT YOU DEFY IMAGINATION?**

Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring a **Specialist Quality Assurance**in **Amgen Singapore Manufacturing**.

**What you will do**

Responsible for ensuring compliance with regulatory requirements at the site level. This role involves managing inspection and audit readiness, execution, and outcomes, as well as coordinating with various stakeholders to support inspection processes. The Specialist Quality Assurance will support activities in both the Biologics and/or Synthetic Manufacturing plants.

Main Responsibilities:

- Lead and support GMP agency and third-party inspections/audits
- Responsible for Internal and Global Quality Compliance auditing program and execution
- Manage inspection logistics, including communication with inspectors, establish inspection team, identifying site/network SME support, inspection package, logistic support for inspectors/ auditors, inspection room set up
- Maintain Site Inspection Readiness
- Conduct training for inspection SMEs and support staff on inspection fundamentals, cultural awareness, and logistics.
- Execute and track Inspection Commitment Applicability Assessments
- Follow up on Site Inspection Commitments to ensure timely closure and adequacy
- Be a Subject Matter Expert (SME) and site representative for Amgen Singapore Manufacturing in Amgen Network for the specified Quality Management System. In case of any system update, new system rollout act as the site project lead.
- Purposefully monitors execution of the specified quality processes and communicates performance and trends to Global Process Owners/Users & Management reviews, applicable SMEs and site/functional/regional management
- Understands process changes and communicates impact to management/users
- Coach site Quality Assurance professionals on resolution of complex problems
- Supporting other Quality Assurance initiatives/activities such as continuous improvement projects, supplier quality, stability program and product quality review.

**What we expect of you**

**Qualifications**
- Doctorate degree in Science OR
- Master’s degree and 2 years of directly related experience OR
- Bachelor’s degree and 4 years of directly related experience OR
- Diploma and 8 years of directly related experience
- 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 regulated 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.
- Experience with regulatory audits and inspections

**Thrive**:
**What you can expect of us**

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.
- Vast opportunities to learn and move up and across our global organization
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

**for a career that defies imagination**:
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

**Equal Opportunity Statement**:
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.