Associate Quality Complaints

Amgen Technology; Hyderabad; Presencial; INR 800.000 - 1.200.000; Jornada completa

Descripción de la vacante

Amgen Hyderabad is seeking to own and implement the end-to-end global complaint process and management system, ensuring compliance with quality operating standards and procedures to meet current and emerging requirements. The role translates market information to drive continuous improvement and aligns cross-functional teams.

The candidate will evaluate triaged records, manage customer feedback through closure, and ensure high-quality documentation while adhering to SOPs and templates across

Formación

• Experience in Pharma/Life Sciences/Biotechnology domains.
• Understanding of quality systems and document control.
• Ability to manage workload to timelines.

Responsabilidades

• Own end-to-end global complaint process and management system.
• Ensure triaged product complaint records stay in sync with procedures.
• Evaluate and manage customer feedback records to closure.
• Complete assigned assessments per procedures.
• Ensure quality of complaint records and drive the process per SOPs.
• Review/approval flow in CDOCS for controlled documents per guidelines.
• Support project tasks with proactive communication and status updates.

Conocimientos

Attention to detail

Communication skills

MS Office

QA experience

Project management

Educación

Bachelor's degree

Master's degree

Descripción del empleo

Job Summary

In this vital role you will own and implements the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement.

Responsibilities

• Evaluates and ensures triaged product complaint records stay in sync with applicable procedures


• Evaluates and manages customer feedback records to closure


• Evaluates records that have been determined to be voided and completes the void process


• Owns records with limited information


• Completes assigned assessments per applicable procedures


• Ensures quality of complaint records


• Drives the complaint process per SOP requirements


• Owns or handles the review/approval process flow in CDOCS of controlled documents; while adhering to format, content, and style guidelines, considering usability, and ensuring accuracy, consistency, and quality according to templates and style guide


• Supports management of assigned projects or project tasks to achieve agreed results within time and with encouraged quality, including (but not limited to) proactive written / in person communication, status updates, tracker tool maintenance

Basic Qualifications

• Bachelor's degree and 3 to 5 years of experience in Pharma/Life Sciences/Biotechnology


• Master's degree and 2 to 4 years of experience in Pharma/Life Sciences/Biotechnology

Preferred Qualifications

• Quality and/or manufacturing experience in biotech, medical device or pharmaceutical industry


• Ability to successfully manage workload to timelines


• Ability to operate in a matrixed or team environment with site, functional, and senior management leadership


• Understanding of quality and industry requirements/expectations of a QMS


• Understanding of the applicable manufacturing/testing processes (i.e., API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)


• Accurate utilization of process management systems (eg Amgen CDOCS for controlled documents or Amgen Learning Management System LMS) to process materials; creation distribution of status reports


• Practical experience with and knowledge of MS Office Applications (e.g. Microsoft Word, Excel)


• Verbal and written communication skills/writing skills


• Technical Learning Skills - ability and willingness to learn new technologies, processes, and methodologies.


• Active listening skills


• Ability to understand and follow processes / process instructions


• Attention to detail