Senior Associate Quality Complaints

2 days ago


Hyderabad, Telangana, India Amgen Inc Full time
Job Description

In this vital role, you will own and implement 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.

The Senior Associate conducts low to medium complexity complaint investigations and determines if complaint investigations require issue for further investigation.

- Evaluates and ensures triaged product complaint records align with applicable procedures.
- Evaluates and owns complaint records with basic investigations.
- Ensures the quality of complaint records.
- Completes assigned assessments per applicable procedures.
- Applies analytical skills to evaluate sophisticated situations using multiple sources of information.
- Implements the complaint process per SOP requirements.
- Owns or manages 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 the 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.

What we expect of you

Basic Qualifications:

- Master's degree and 1 to 3 years of Quality experience OR
- Bachelor's degree and 3 to 5 years of Quality experience OR
- Diploma and 7 to 9 years of Quality experience.

Preferred Qualifications:

- Quality and/or manufacturing experience in the biotech, medical device, or pharmaceutical industry.
- Bachelor's Degree in a Science Field.
- Ability to successfully manage workload to timelines.
- Familiarity with basic project management tools.
- Ability to operate in a matrixed or team environment with site, functional, and senior management leadership.
- Experience in driving decision-making by using the DAI principles.
- 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).
- Ability to negotiate a position after taking feedback from multiple sources.
- Demonstrated ability to lead functional teams, consistently deliver timely, and high-quality results.
- Ability to translate business and key collaborator feedback and requirements into accurate and efficient processes using clear language and format.

  • Hyderabad, Telangana, India Amgen Technology Private Limited Full time

    Job DescriptionWe are seeking a Senior Associate Quality Complaints professional to own and implement the end-to-end global complaint process and management system. This is a vital role that ensures our complaint processes and systems remain compliant with current internal and external requirements. The ideal candidate will be skilled in conducting low to...


  • Hyderabad, Telangana, India Amgen Technology Private Limited Full time

    Job DescriptionIn this vital role, you will own and implement the end-to-end global complaint process and management system. You will supervise a team of complaint investigators, ensuring that the entire process remains compliant with quality operating standards, procedures, and regulatory requirements. This position focuses on assuring the quality of...


  • Hyderabad, Telangana, India Amgen Inc Full time

    Job Description- Ensure execution of the quality complaint process in compliance with procedures, laws, and regulations.- Maintain high quality in complaint records and related tasks.- Lead team initiatives and projects focused on process and performance improvement.- Establish clear performance expectations and drive daily improvement.- Prioritize workload...


  • Hyderabad, Telangana, India Bristol-Myers Squibb Full time

    Working with Us Challenging Meaningful Life-changing Those aren t words that are usually associated with a job But working at Bristol Myers Squibb is anything but usual Here uniquely interesting work happens every day in every department From optimizing a production line to the latest breakthroughs in cell therapy this is work that transforms the...


  • Hyderabad, Telangana, India Amgen Inc Full time

    Job Description- Drive execution of the global complaints business process and continuous improvement- Maintain oversight of complaints throughout the lifecycle from intake, processing, and through closure- Apply in-depth knowledge and subject matter expertise to determine the steps necessary to improve the complaint management system to address the root...


  • Hyderabad, Telangana, India beBeeCompliance Full time ₹ 17,59,550 - ₹ 21,39,340

    Complaint Resolution LeadAs a key member of the Amgen team, you will play a vital role in overseeing the global complaints business process and driving its continuous improvement. This position is critical to maintaining oversight of complaints throughout their lifecycle from intake, processing, and closure.Key Responsibilities:Apply in-depth knowledge and...


  • Hyderabad, Telangana, India beBeeQualityOperations Full time ₹ 15,00,000 - ₹ 25,00,000

    Job Opportunity: Product Complaints Specialist">Job DescriptionThe Product Complaints Specialist is responsible for processing market complaints in line with relevant standard operating procedures (SOPs), business matrices, and service level agreement (SLA) timelines. Key responsibilities include data collection, reporting of key performance indicators...


  • Hyderabad, Telangana, India beBeeManagement Full time ₹ 2,00,00,000 - ₹ 2,50,00,000

    Complaint Handling LeadTo be successful in this role, you will need to lead the complaint handling team and oversee the quality complaint process ensuring compliance with established procedures, laws, and regulations.


  • Hyderabad, Telangana, India beBeeQuality Full time ₹ 2,00,00,000 - ₹ 2,50,00,000

    Quality Assurance Manager RoleThis role requires a professional to oversee the implementation and maintenance of a quality management system.Main ResponsibilitiesDeveloping, maintaining, and enhancing the organization's quality management system.Identifying opportunities for continuous improvement within the system.Creating quality procedures aligned with...


  • Hyderabad, Telangana, India Thepharmadaily Full time

    Job Description- Handle Product Technical Complaints and Field Alerts for medical devices, pharmaceutical products, biologics, and combination products, ensuring compliance with regulatory standards.- Evaluate complaints for severity and risk, ensuring timely review and processing.- Prioritize and enter complaints into the global database, monitoring...