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Specialist Quality Assurance

2+ years
Not Disclosed
10 Nov. 26, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Specialist Quality Assurance
Amgen Singapore Manufacturing

Join Amgen’s Mission of Serving Patients

At Amgen, we are driven by our shared mission to serve patients living with serious illnesses. Since 1980, we have helped pioneer the biotechnology industry in the fight against some of the world’s most challenging diseases. Focused on four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease—we impact millions of patients annually. As part of the Amgen team, you will have the opportunity to make a lasting difference in the lives of patients as we research, manufacture, and deliver innovative medicines that help people live longer, fuller, and happier lives.

Our award-winning culture is collaborative, innovative, and science-based. If you have a passion for challenges and the opportunities they present, you’ll thrive as part of our team. Join us, and help transform the lives of patients while advancing your career.


What You Will Do

As a Specialist Quality Assurance, you will be responsible for overseeing sophisticated projects involving strategic planning, development, and execution of Software Development Lifecycle (SDLC) deliverables. You will be involved in all phases of computerized systems validation/assurance, including planning, requirements gathering, testing (e.g., IQ, OQ), and approval of documentation. You will offer guidance and technical expertise while collaborating with various teams to meet organizational goals and drive improvements.


Key Responsibilities:

  • Quality Assurance Oversight: Take ownership of assigned records/tasks. Evaluate validation and qualification packages of computerized systems to ensure they meet regulatory expectations and are complete and accurate.
  • Documentation Review: Initiate, review, and approve Change Controls, deviations, problem records, and CAPA records (e.g., TrackWise/Veeva, ServiceNow).
  • Compliance: Ensure compliance with GxP regulations (e.g., GMP, GLP, GCP, GPvP, and GDP standards) and conduct thorough data analysis to compare results against acceptance criteria.
  • Continuous Improvement: Support continuous improvement activities, training initiatives, and contribute to strategic management processes as needed.
  • Regulatory Support: Participate in regulatory inspections, support Supplier Evaluations, and assist with Integrated Systems Assessments (ISA) and Management Review Processes.

What We Expect of You

We value the unique contributions of every individual at Amgen. The ideal candidate will demonstrate the following qualifications:

Basic Qualifications:

  • Master’s degree and 4 to 6 years of technical field experience, OR
  • Bachelor’s degree and 6 to 8 years of technical field experience, OR
  • Diploma and 10 to 12 years of technical field experience

Preferred Qualifications:

  • Work Experience: 3-5 years in Computer System Validation, Quality Assurance processes within a regulated industry (preferably in Biotechnology or Pharmaceuticals).
  • Regulatory Knowledge: In-depth understanding of GxP regulations, including GMP, GLP, GCP, GPvP, and GDP standards.
  • Technical Expertise: Extensive knowledge of Information Systems such as LIMS, CDOCS, SAP, and Maximo.
  • Problem-Solving Skills: Strong analytical skills to resolve complex quality issues with multiple data sources.
  • Leadership: Ability to lead projects or teams, drive tasks to completion, and work independently with minimal supervision.

What You Can Expect of Us

At Amgen, we’re committed to your professional and personal growth. You can expect:

  • Learning and Career Development: Vast opportunities for learning and career advancement within a global organization.
  • Inclusive Environment: A diverse and inclusive community where teammates are empowered to bring ideas to the table and act.
  • Competitive Rewards: A comprehensive Total Rewards Plan, offering health, financial, and work/life balance benefits.