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Specialist Quality Assurance

2+ years
Not Disclosed
12 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, our mission is clear: to serve patients living with serious illnesses. Since 1980, we've been at the forefront of biotechnology, pioneering solutions in the fight against some of the world’s most difficult diseases. Our focus spans Oncology, Inflammation, General Medicine, and Rare Disease, helping millions of patients each year. As part of the Amgen team, you will make a lasting impact as we research, manufacture, and deliver innovative medicines to improve lives and health outcomes.

Join our collaborative, innovative, and science-driven culture. If you are passionate about tackling challenges, you will thrive in this dynamic environment. Become part of our mission to change the lives of patients and transform your career.


What You Will Do
In this crucial role, you will be responsible for managing sophisticated projects, including strategic planning, development, and execution of software development lifecycle deliverables. You will engage in all phases of computerized systems validation/assurance, from planning to testing (e.g., IQ, OQ) and final approval of documentation. You will also provide guidance, technical insights, and collaborate with various teams to meet organizational goals.


Responsibilities

  • Quality Assurance Oversight: Take ownership of assigned records and tasks, evaluating validation and qualification packages to ensure they meet regulatory expectations.
  • Compliance & Risk Management: Ensure compliance with validation policies and procedures, conducting data analysis to compare results against acceptance criteria and raise critical issues to management as needed.
  • Documentation & Approvals: Initiate, review, and approve Change Controls (e.g., TrackWise/Veeva, ServiceNow), deviations, problem records, CAPA, Efficiency Verification (EV) records, and validation documentation.
  • Standard Operating Procedures (SOPs): Review and approve operational, administrative SOPs, work instructions, Data Integrity Assessments (DIA), system periodic reviews, and audit trails.
  • Continuous Improvement: Support continuous improvement activities, training initiatives, and management review processes.
  • Regulatory Support: Participate in and support regulatory inspections, ensuring that compliance is maintained across all operations.

What We Expect of You

Basic Qualifications:

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

Preferred Qualifications:

  • Demonstrated experience in Computer System Validation, Quality Assurance processes within a regulated industry (preferably Biotechnology/Pharmaceutical)
  • In-depth experience in the validation of computerized systems and quality assurance processes
  • Regulatory expertise in interpreting and applying GxP regulations, including GMP, GLP, GCP, GPvP, and GDP standards
  • Technical proficiency with systems such as LIMS, CDOCS, SAP, and Maximo
  • Strong problem-solving, decision-making, and analytical skills
  • Ability to work independently with minimal supervision and lead projects or teams as required

What You Can Expect of Us

At Amgen, we support both your professional growth and personal well-being. You will benefit from a competitive salary, comprehensive Total Rewards Plans aligned with industry standards, and a collaborative work culture.