Job Title: Associate – Quality Complaints
Location: Hyderabad, India
Employment Type: Full-Time (On-Site)
Posted: September 30, 2024
Job ID: R-198186
About the Role:
Amgen is seeking a detail-oriented Associate – Quality Complaints to manage and oversee the end-to-end global complaint process within our quality systems. In this role, you will ensure complaint management processes remain compliant with internal procedures and global regulatory standards while translating customer feedback into actionable insights for continuous improvement.
Key Responsibilities:
Own and manage complaint investigations, including records with limited information and those requiring no further investigation.
Evaluate complaint records to determine if critical issues need escalation for higher-level review.
Ensure triaged product complaint records adhere to applicable procedures and are properly closed.
Perform void processes for records deemed non-actionable and maintain accurate documentation.
Review and approve controlled documents in CDOCS, ensuring compliance with formatting, style, and content standards.
Support assigned projects or project tasks, including communication, status updates, and tool maintenance.
Drive continuous process improvement based on market feedback and internal audit outcomes.
Maintain compliance with GxP regulations, EMA/FDA standards, and company SOPs.
Minimum Requirements:
Bachelor’s degree with 0–3 years of experience in Data Sciences, Biochemistry, Chemical Engineering, or related scientific fields, OR
Diploma with 4–7 years of experience in the same fields.
Strong verbal and written communication skills.
Attention to detail and ability to follow documented processes accurately.
Critical thinking and problem-solving skills in quality-related tasks.
Ability to manage multiple tasks or projects concurrently.
Preferred Qualifications:
Familiarity with tools such as Smartsheet, Veeva, Microsoft Copilot, OpenAI GPT, and other AI/LLM platforms.
Knowledge of Quality Management, Document Management, or Learning Management Systems (LMS).
Practical experience with MS Office applications (Word, Excel, Visio).
Understanding of regulatory standards (EMA, FDA) and ethical guidelines in the pharmaceutical industry.
Ability to translate feedback into efficient, compliant processes and documentation.
Work Location: On-Site – Hyderabad, India
Why Join Us:
At Amgen, you will contribute to life-changing therapies while developing your career in a collaborative, innovative, and science-driven environment. Our competitive benefits and inclusive culture ensure professional growth and well-being while making a tangible impact on patient lives globally.
Equal Opportunity Statement:
Amgen is an equal opportunity employer and considers all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other legally protected status. Reasonable accommodations are available for individuals with disabilities.
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