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Specialist Qa I

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

HOW MIGHT YOU DEFY IMAGINATION?
Amgen is a global leader in biotechnology, dedicated to pioneering breakthroughs that bring state-of-the-art medicines from the laboratory to the patient. With over four decades of innovation, Amgen has not only developed groundbreaking human therapeutics but also invested in cutting-edge manufacturing capabilities to deliver these therapies worldwide. As the fastest growing region for Amgen, Japan and Asia Pacific (JAPAC) is an area of major focus, and we are now hiring a Specialist Quality Assurance to join Amgen Singapore Manufacturing.


What You Will Do
In this key role, the Specialist Quality Assurance will provide oversight and leadership for quality systems execution and operational support across several functions, including Facilities & Engineering (F&E), Quality Control (QC), Supply Chain, Digital Technology & Innovation (DTI), Process Development (PD), and Validation. This includes supporting both Biologics and Synthetic Manufacturing plants at various stages, including commissioning, process qualification, regulatory approval, and market supply.

Main Responsibilities:

  • Provide quality oversight to plant operations, ensuring adherence to GMP compliance requirements and the execution of the Amgen Quality Management System throughout various operational phases.
  • Support routine GMP documentation review, including SOPs, logbooks, work orders, validation documents, and periodic reviews to ensure key performance indicators are met.
  • Co-lead and support the deployment of Amgen’s quality systems such as management review, validation, deviation management, change control, and CAPA.
  • Review and approve deviations, investigations, unexpected result investigations, change controls, and other quality records, focusing on complex cases. Lead complex root cause investigations for deviations.
  • Provide Quality Assurance support to New Product Introduction (NPI) teams.
  • Coach site Quality Assurance professionals in resolving complex issues.
  • Participate in regulatory inspections and engage directly with regulatory inspectors.
  • Support continuous improvement projects, supplier quality initiatives, stability programs, and product quality reviews.

Qualifications

  • Doctorate degree in Science OR
  • Master’s degree and 4 years of directly related experience OR
  • Bachelor’s degree and 6 years of directly related experience OR
  • Diploma and 8 years of directly related experience

Preferred Qualifications:

  • 8+ years of related work experience in manufacturing, process development, or quality assurance in the pharmaceutical/biologics industry with progressive responsibility.
  • Experience with bulk manufacturing of biopharmaceuticals/API.
  • Demonstrated proficiency in written and verbal communication, including technical writing and presentations, and the ability to collaborate with senior management and technical staff.
  • Experience with regulatory audits and inspections.
  • Strong problem-solving skills with the ability to analyze data, make informed decisions, and resolve compliance and product quality issues.

What You Can Expect of Us
At Amgen, we prioritize the professional and personal growth of our teammates. You can expect:

  • Vast opportunities for learning and career advancement across our global organization.
  • A diverse and inclusive community where teammates are empowered to contribute ideas and take action.
  • A generous Total Rewards Plan that includes health, financial, and work/life balance benefits.

Apply Now
Join us in a career that defies imagination and helps make a lasting impact. [Apply Now] at Amgen.