Amgen - Senior Associate - Quality Complaints

Description:

Join Amgens Mission of Serving Patients: At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Senior Associate Quality Complaints:

What you will do:

- Own and implement the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen.

- Conduct low to medium complexity complaint investigations and determine if investigations require further action.

- Evaluate and ensure triaged product complaint records align with applicable procedures.

- Evaluate and own complaint records with basic investigations.

- Ensure quality of complaint records and complete assigned assessments per applicable procedures.

- Apply analytical skills to evaluate sophisticated situations using multiple sources of information.

- Implement the complaint process per SOP requirements.

- Own or manage the review/approval process flow in CDOCS of controlled documents.

- Support management of assigned projects or project tasks to achieve agreed results.

- Due to the global nature of the role, must be willing to work in shifts that overlap with EU and US time zones, if required.

Basic Qualifications:

- Masters degree and 4-7 years of Quality experience OR Bachelors degree and 5-9 years of Quality experience.

Preferred Qualifications:

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

Requirements:

- Ability to successfully manage workload to timelines and 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. Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

Location: Hyderabad, Telangana.

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