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    Specialist Quality Assurance

    Amgen
    2+ years
    Not Disclosed
    Hyderabad
    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 at Amgen

    Join Amgen’s Mission of Serving Patients

    At Amgen, our shared mission—to serve patients living with serious illnesses—drives everything we do. Since 1980, we’ve led the biotech industry in the fight against the world’s toughest diseases. With a focus on Oncology, Inflammation, General Medicine, and Rare Disease, we reach millions of patients each year. As part of the Amgen team, you’ll play a vital role in researching, manufacturing, and delivering innovative medicines that help people live longer, fuller, and happier lives.

    Our award-winning culture is collaborative, innovative, and science-driven. If you are passionate about facing challenges and seizing growth opportunities, you will thrive at Amgen. Join us and help transform the lives of patients while advancing your career.

    What You Will Do

    In this essential role, you will be responsible for managing sophisticated projects, strategic planning, and the execution of Software Development Lifecycle deliverables. You will be involved in all stages of computerized systems validation/assurance, from planning and requirements to testing (e.g., IQ, OQ) and approval of supporting documentation. You will offer technical guidance and collaborate across teams to meet organizational goals.

    Responsibilities

    • Quality Assurance Ownership: Take full responsibility for evaluating validation and qualification packages to ensure they meet regulatory standards and are complete and accurate.
    • Compliance & Data Analysis: Ensure compliance with validation policies and procedures, conduct data analysis to compare results against acceptance criteria, and address any issues with management.
    • Change Control & Documentation: Initiate, review, and approve Change Controls, deviations, and problem records using systems like TrackWise/Veeva and ServiceNow. Oversee validation documentation and SOPs.
    • Regulatory & Continuous Improvement: Participate in regulatory inspections, support Continuous Improvement activities, and assist with management reviews and training initiatives.
    • Audit Support & System Assessments: Review system periodic reports, support supplier evaluations, and engage in the Integrated Systems Assessment (ISA) process.

    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:

    • 3-5 years of experience in Computer System Validation and Quality Assurance in a regulated industry (preferably in Biotechnology or Pharmaceuticals)
    • Knowledge of GxP regulations, including GMP, GLP, GCP, GPvP, and GDP
    • Experience with information systems such as LIMS, CDOCS, SAP, and Maximo
    • Strong analytical and problem-solving abilities, capable of resolving complex quality issues using diverse data sources
    • Strong decision-making skills with the ability to drive tasks to completion
    • Independent work style and leadership experience managing projects or teams

    What You Can Expect of Us

    Amgen is committed to supporting your professional and personal growth. We offer competitive salaries and comprehensive Total Rewards Plans aligned with industry standards. Our collaborative culture will help you succeed while contributing to our mission and your career development.

    Apply Now

    For a career that challenges you and helps change the world for patients, [Apply Now] at Amgen.

    Amgen is an Equal Opportunity Employer

    Amgen fosters a diverse, inclusive environment and will consider all qualified applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status, or any other basis protected by applicable law. We ensure individuals with disabilities receive reasonable accommodations to participate in the application or interview process and perform essential job functions. Please contact us for accommodation requests.

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    Bucharest |

    Makkah :

    Khulais | Rabigh | Najran | Riyadh | Jeddah | King Abdullah Economic City |

    Nišava District :

    Niš |

    Singapore :

    Singapore |

    South Africa :

    Midrand | South Africa |

    Brazil :

    Brazil | Sao paulo |

    South America :

    Argentina | Peru |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Sweden :

    Sweden |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hanoi | Hà Nội |

    Ho Chi Minh :

    Ho Chi Minh City |