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Amgen
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Senior Associate Quality Complaints

Senior Associate Quality Complaints

Amgen

1 - 3 years

3 - 5 Lacs

Hyderabad

Posted:6 days ago| Platform:

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Skills Required

Analytical skills Biotechnology Project management Pharma Packaging Oncology Continuous improvement Tool maintenance

Work Mode

Work from Office

Job Type

Full Time

Job Description

Let s do this. Let s change the world. 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.

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 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 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

We are all different, yet we all use our unique contributions to serve patients.

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 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

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

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Senior Associate Quality Complaints