Specialist Quality Assurance

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Specialist Quality Assurance

Apply remote type Flex Commuter / Hybrid locations Singapore Manufacturing - Tuas time type Full time posted on Posted 2 Days Ago job requisition id R-207170

Career Category

Quality

Job Description

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 .

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 indicators 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.

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.

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.

About Us

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. #J-18808-Ljbffr