Epicareer Might not Working Properly
Learn More
Please Turn on your JavaScript

Epicareer might not working properly because your browser javascript is turned off.

What is JavaScript?

JavaScript is like the magic behind making websites interactive. Basically, it makes Epicareer more enjoyable and engaging.
How do i turn this on?
Find tutorial for your browser below :
  1. Make sure the webpage is open.
  2. In the Safari app on your Mac, choose Safari > Preferences, then click Security.
  3. Make sure the Enable JavaScript checkbox is selected.
  4. Click Websites.
  5. On the left, click Content Blockers.
  6. Make sure Off is chosen in the pop-up menu next to the website.
  7. On the left, click Pop-up Windows.
  8. Make sure Allow is chosen in the pop-up menu next to the website.
Visit Site here
  1. Open Chrome on your computer.
  2. Click. then Settings.
  3. Click Privacy and Security.
  4. Click Site settings.
  5. Click JavaScript.
  6. Select Sites can use Javascript.
Visit Site here
  1. If you're running Windows OS, in the Firefox window, click Tools > Options.
  2. Tip: If you're running Mac OS, click the Firefox drop-down list > Preferences.
  3. On the Content tab, click the Enable JavaScript check box.
Visit Site here
  1. Click the "Settings and more" icon at the top right of the Edge browser window.
  2. Click Settings.
  3. From the Settings menu, click Cookies and site permissions.
  4. Scroll down and click on JavaScript.
  5. In the JavaScript window, toggle the slider to "on" or "allowed."
  6. Close the Settings tab.
  7. Refresh the page.
Visit Site here
  1. Go to Settings.
  2. Click Advanced in the left sidebar, and click Privacy & security.
  3. Under Privacy and security, click Site settings.
  4. Click JavaScript.
  5. At the top, turn on or off Allowed (recommended).
Visit Site here
Any Question? Contact us
logo
Jobs or company...

Specialist Quality Assurance

Salary undisclosed
Checking job availability...
Original
Simplified
Career Category QualityJob DescriptionSpecialist Quality AssuranceAmgen Singapore ManufacturingHOW 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.LiveWhat you will doResponsible 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.
WinWhat we expect of youQualifications
  • 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.ThriveWhat you can expect of usAs 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 nowfor a career that defies imaginationIn our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.careers.amgen.comEqual Opportunity StatementAmgen 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..