Role Summary
Amgen is hiring an Associate - Quality Complaints for its Quality team in Hyderabad, Telangana (On Site). In this quality operations role, you will execute and manage end-to-end global product complaint processes, evaluate customer feedback records, and ensure strict compliance with internal SOPs, Quality Management Systems (QMS), and regulatory expectations across biopharmaceutical and medical device products.
Key Responsibilities
- Complaint Process Management: Conduct complaint investigation tasks, evaluate customer feedback records to closure, and process voided or limited-information complaint records per SOP requirements.
- Document Control & Compliance: Handle the review and approval flow of controlled quality documents in CDOCS, adhering to formatting, usability, and style guidelines.
- Issue Escalation & Quality Assurance: Determine if product complaint records require higher-level critical issue escalation and ensure data integrity across the global complaint management system.
- Project Support & Tracking: Maintain project status reports, tracking tools, and Learning Management System (LMS) materials while communicating updates to key stakeholders.
Key Qualifications
- Education: Bachelor’s degree in Pharma, Life Sciences, Biotechnology, or a related discipline (with 2–4 years of experience) OR Master’s degree (with 1–3 years of experience).
- Experience: 1–4 years of relevant quality assurance, complaint management, or manufacturing experience within the pharmaceutical, biotech, or medical device industries.
- Mandatory Technical Stack: Quality Management Systems (QMS), SOP execution, CDOCS, MS Office (Word, Excel), and technical writing.
- Preferred Exposure: Understanding of API, Drug Substance, Drug Product packaging, and medical device manufacturing processes.
About Amgen
Amgen is a global biotechnology pioneer dedicated to serving patients living with serious illnesses across Oncology, Inflammation, General Medicine, and Rare Diseases.