Specialist Quality Assurance

3 days ago

Singapore Amgen SA Full time

Specialist Quality Assurance
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 .
Live
What you will do
Responsible for providing oversight and leadership for quality systems execution and operations support, the Specialist Quality Assurance will support activities in both the Biologics and/or Synthetic Manufacturing plants.
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, process 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
Be a 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
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
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
Review and approve deviations, investigations, unexpected 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 support in New Product Introduction (NPI) team
Coach site Quality Assurance professionals on resolution of complex problems
Participate in regulatory inspections, and interact directly with regulatory inspectors
Supporting other Quality Assurance initiatives/activities such as continuous improvement projects, supplier quality, stability program and product quality review.
Win
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 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.
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
Apply now
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.
careers.amgen.com
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.
We will ensure that individuals with disabilities are provided a 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 an accommodation.
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