Sr. Associate, Quality Compliance

1 day ago

Hyderabad Telangana, India Amgen Full time

Career Category Quality ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world s toughest diseases and make people s lives easier fuller and longer We discover develop manufacture and deliver innovative medicines to help millions of patients Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation using technology and human genetic data to push beyond what s known today ABOUT THE ROLE Role Description The senior associate will work within R D Quality s Business Intelligence and Data Analytics BIDA team to help deliver actionable information and recommendations to key leaders and stakeholders by maintaining and expanding our data pipelines tools and reporting This role contributes to ensuring Amgen s pursuit of life-saving medication is done with the highest regard for quality and compliance to regulations Roles Responsibilities As an integral team member working globally with BIDA other R D Quality team members and R D Quality stakeholders to ensure quality across our trials and compliance with GxP regulations and other requirements Extract and clean data from internal systems for regular and ad hoc reporting including data pipeline creation and maintenance Generate validate and deliver KPIs quality metrics and performance indicators used across the R D Quality landscape Investigate and analyze metric trends anomalies and operational insights Design build and maintain Tableau dashboards for operational monitoring compliance reporting and executive summaries Develop and maintain Python scripts used for data processing transformation and report automation Help create reusable components for common data analysis tasks and documentation Ensure version control and proper documentation of scripts and workflows Basic Qualifications and Experience Master s degree and 7-10 years in Pharma and Biotechnology R D Quality OR Bachelor s degree and 10-15 years of years in Pharma and Biotechnology R D Quality Functional Skills Must-Have Skills Exceptional attention to detail and accuracy in all deliverables Ability to work independently and proactively in a fast-paced environment Proficiency with Tableau or similar data visualization tools Familiarity with Python or other object-oriented programming language Familiarity with SQL and Databricks Proficiency in Microsoft Office Suite Word Excel PowerPoint Outlook and virtual collaboration tools e g Teams Effective communication critical thinking and problem-solving Experience in conducting data analyses and translating data sets into actionable insights Good-to-Have Skills Familiarity with project management tools and methodologies Knowledge of GCP GLP and or GPvP Familiarity with Databricks and SQL Experience working in a multinational environment with global teams Experience within Biotech pharmaceutical Research Independent and teamwork capabilities Soft Skills Excellent verbal and written communication skills High degree of professionalism and interpersonal skills Strong problem-solving abilities and adaptability to changing priorities Collaborative mindset and ability to build positive relationships across diverse teams Resilience discretion and the ability to thrive under pressure

  • Associate Quality Compliance

    1 week ago

    Hyderabad, Telangana, India Amgen Full time

    **Role Name**:Associate Quality Compliance **Department Name**:R&D Quality **Role GCF: 3** **ABOUT AMGEN** Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen...

  • Sr Associate Quality Compliance

    2 weeks ago

    Hyderabad, Telangana, India Amgen Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Role Name: Sr Associate Quality Compliance – Documentation LeadDepartment Name: R&D QualityRole GCF: 4ABOUT AMGENAmgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen...

  • Reg Compliance Change Assessor

    1 day ago

    Hyderabad, Telangana, India Amgen Full time

    Career Category Regulatory Regulatory Affairs Chemistry Manufacturing and Controls RA CMC facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle Amgen s Regulatory Compliance team...

  • Sr. Associate Quality Compliance

    6 days ago

    Hyderabad, Telangana, India Amgen Inc Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    Department Name: R&D QualityRole GCF: 4Role Description:The Sr Associate Quality Compliance - Process Modeler gathers and analyses information from a variety of sources (SMEs, documentation, and technical) to create business process models within the Amgen process modeling methodology framework, using specified Visio templates. In addition, the Process...

  • Sr Associate Quality Compliance

    5 days ago

    Hyderabad, Telangana, India Amgen Inc Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    R&D Quality Senior AssociateWhat you will doIn this vital role the R&D Quality Senior Associate will play a crucial part in ensuring our organization's compliance with regulatory standards and preparing and coordinating a cross-functional team for Regulatory Health Authority inspections globally. The role also involves supporting the development of...

  • Sr Associate Quality Compliance

    2 weeks ago

    Hyderabad, Telangana, India Amgen Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    If you feel like you're part of something bigger, it's because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that read over 10...

  • Sr. Associate, Quality Compliance

    2 days ago

    Hyderabad, Telangana, India Amgen Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    ABOUT AMGENAmgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of...

  • Quality Compliance Associate

    4 days ago

    Hyderabad, Telangana, India Amgen Technology Private Limited Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    Associate Quality Compliance Career CategoryQuality Job Description Role Name: Associate Quality Compliance Department Name: R&D Quality Role GCF: 3 ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and...

  • Sr. Associate, Quality Compliance

    4 days ago

    Hyderabad, Telangana, India Amgen Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    Career CategoryQualityJob DescriptionABOUT AMGENAmgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago...

  • Associate Quality Compliance

    7 days ago

    Hyderabad, Telangana, India Amgen Full time ₹ 4,00,000 - ₹ 8,00,000 per year

    Role Name: Associate Quality ComplianceDepartment Name: R&D QualityRole GCF: 3ABOUT AMGENAmgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the...