Specialist Quality Assurance

Biopharma Careers; Singapore; On-site; SGD 90,000 - 120,000; Full time

Job summary

Amgen Singapore Manufacturing is seeking a Specialist Quality Assurance to lead Quality Management Systems, serve as SME for the site, and act as the local representative for system updates and rollouts.

Responsibilities include managing deviations, CAPAs, training, audits, and inspection readiness; collaborating with Global Process Owners and regional teams; and driving process improvements while mentoring staff.

Qualifications

• 8 years related work experience in pharma/biologics with increasing responsibility.
• Experience with bulk manufacturing of biopharmaceuticals/API preferred.
• Strong written and verbal communication for technical writing and presentations.

Responsibilities

• Manages Quality Management Systems deviations and CAPA/EVs.
• Acts as SME and site representative for Amgen Singapore Manufacturing QMS.
• Leads system updates and rollout projects at the site.
• Ensures inspection readiness and alignment with quality process requirements.
• Interacts with Global Process Owners, management, and regulatory bodies.

Skills

Quality Assurance

CAPA

Auditing

Documentation

Coaching

Regulatory knowledge

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Diploma

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

What you will do

Responsible for assigned Quality Management Systems (Deviation/CAPA). 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.

Responsibilities

• Manages the implementation of process changes and ensures consistent execution of the applicable quality processes in the site
• Purposefully monitors execution of the specified quality processes and communicates performance to Global Process Owners/Users & Management
• Understands process changes and communicates impact to management/users
• Attends network/collaboration group meetings and represents site/functional challenges, lessons learned, audit and inspection findings and best practices
• Reviews applicable Global Standard, and may author or QA process documentation or training materials
• On-boards new users; provides training, facilitates learning groups and is a coach/mentor to users
• Escalates performance issues and trends to the Global Process Owners, site management reviews, applicable SMEs and site/functional/regional management
• Ensures inspection readiness and applicable local procedures are in alignment with quality process requirements and QMS architecture
• Represents process during audits and regulatory agency inspections.
• Engages with GPO when commitments are made after regulatory inspections
• Develops and owns site/region specific commitments for process
• Participates in process improvements initiated by the GPO/Network
• May lead process improvements projects across the site/function/region.
• May own site /function Deviations, CAPA/EVs, and change records for process
• QA contact for site /function Deviations, CAPA/EVs and change control records

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

What we expect of you

• Doctorate degree 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

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.

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.