Associate Quality Complaints

By Admin · Quality Assurance & Quality Control

HYDERABAD (IN)ONSITEPOSTED: 9/30/2026
PHARMAFull-time
HIRING ORGANIZATIONAMGENBiotechnology / Pharmaceuticals
Amgen

ROLE OVERVIEW

Own and execute quality complaint activities across the global complaint process, ensuring compliant handling, accurate records, timely closure, and appropriate escalation. The role connects customer feedback with quality processes and continuous improvement.

ROLE DEFINITION & RESPONSIBILITIES

  • •Evaluate and ensure triaged product complaint records remain aligned with applicable procedures
  • •Evaluate and manage customer feedback records through closure
  • •Evaluate records determined to be voided and complete the void process
  • •Own and manage complaint records with limited information
  • •Complete assigned assessments according to applicable procedures
  • •Ensure accuracy and quality of complaint records and drive complaint processes according to SOP requirements
  • •Own or handle controlled-document review and approval workflows in CDOCS while maintaining required format, content, usability, accuracy, consistency, and quality
  • •Support assigned projects through timely communication, status updates, tracker maintenance, and tool management
Reporting Hierarchy: Reports to quality/complaint management leadership within a global, matrixed organization; Team structure and direct-report information are not specified in the source posting

* Role responsibilities and qualifications synthesized based on industry benchmark standards.

QUALIFICATIONS & REQUIREMENTS

REQUIRED QUALIFICATIONS

  • Bachelor's degree with 3-5 years of experience in Pharma, Life Sciences, or Biotechnology
  • OR Master's degree with 2-4 years of experience in Pharma, Life Sciences, or Biotechnology
  • Ability to understand and follow processes and process instructions
  • Strong attention to detail and written/verbal communication skills

PREFERRED QUALIFICATIONS

  • •Quality or manufacturing experience in biotechnology, medical device, or pharmaceutical industry
  • •Understanding of QMS requirements and applicable manufacturing/testing processes
  • •Experience with controlled-document or learning management systems
  • •Practical experience with Microsoft Word and Excel
  • •Experience working in matrixed or cross-functional teams

REQUIRED VERIFIED SKILLS

Quality complaint management
Complaint investigation
Quality Management System (QMS)
SOP compliance
Customer feedback management
Complaint records
CAPA awareness
GMP
CDOCS
Controlled document management
Microsoft Word
Microsoft Excel
Quality systems

COMPENSATION & REWARDS

Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Competitive and comprehensive Total Rewards aligned with local industry standards; professional and personal growth and well-being support
The source posting does not disclose a salary range or bonus/equity amount. Compensation should therefore be evaluated using the employer's formal offer and current market data for comparable pharmaceutical quality roles in Hyderabad rather than an inferred figure.

ORGANIZATION CONTEXT & CULTURE

Amgen is a global biotechnology company founded in 1980 that develops, manufactures, and delivers innovative medicines intended to help patients living with serious illnesses. Its stated focus includes Oncology, Inflammation, General Medicine, and Rare Disease.

TEAM SIZE: 50,000+ employees
INDUSTRY: Biotechnology / Pharmaceuticals
Culture: Amgen describes its culture as collaborative, innovative, science-based, inclusive, and focused on serving patients while advancing science.

EXPECTED CAREER ROADMAP

The role can provide progression within pharmaceutical quality operations into Quality Complaints, Quality Assurance, Quality Systems, Quality Compliance, or broader quality-management responsibilities. Experience with complaint processes, QMS, controlled documents, and cross-functional quality activities can support advancement into specialist, senior associate, and management-level quality roles.

APPLICATION ADVISORY

Highlight experience handling quality records, customer complaints, investigations, SOP-driven workflows, and QMS processes; demonstrate strong attention to detail and documentation accuracy; emphasize pharmaceutical, biotechnology, medical-device, or manufacturing quality experience; mention experience with document-management systems and Microsoft Excel/Word; prepare examples showing timely case closure, escalation judgment, and cross-functional communication.

READY TO SUBMIT?

Verify your capability profile and matching credentials before submitting direct applications.