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Amgen
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Specialist Quality Complaints

Specialist Quality Complaints

Amgen

4 - 6 years

14 - 16 Lacs

Hyderabad

Posted:2 days ago| Platform:

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Skills Required

Biotechnology Project management Analytical Pharma Packaging Oncology Subject Matter Expert Continuous improvement

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 conduct complex complaint investigations, resolves corrective actions with their effectiveness and resolves steps necessary to ensure the proper level of control for product in distribution.

We are seeking a Specialist Quality Complaints Complaint Owner and member of the Product Complaints and Surveillance team. The Product Complaints and Surveillance team owns 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.

Ensures quality of complaint records
Applies analytical abilities to evaluate complex situations using multiple sources of information
Execution of regulatory and SOP requirements
Anticipates and prevents potential issues with regulators
Provides guidance and technical advice
Evaluates subject matter expert assessments
Raises potential Quality issues to Management

What we expect of you

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

Basic Qualifications:

Doctorate degree OR ,
Master s degree and 4 to 6 years of Specialist Quality Complaints experience OR ,
Bachelor s degree and 6 to 8 years of Specialist Quality Complaints experience OR ,
Diploma and 10 to 12 years of Specialist Quality Complaints experience

Preferred Qualifications:

Quality and manufacturing experience in biotech or pharmaceutical industry
Ability to oversee multiple projects simultaneously
Ability to successfully handle workload to timelines
Familiarity with basic project management tools
Ability to negotiate a position after taking feedback from multiple sources
Demonstrated ability to consistently deliver on-time, and high-quality results
Ability to operate in a matrixed or team environment
Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)

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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