Senior Associate Quality Complaints

Amgen Inc

1 - 3 years

3 - 5 Lacs

hyderabad

Posted:15 hours ago| Platform:

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Skills Required

manufacturing processes sop qms quality assurance manufacturing project management quality control quality audit autocad catia new product development kaizen change control quality management solid works creo pro-e production planning ppap gd

Work Mode

Work from Office

Job Type

Full Time

Job Description

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

Basic Qualifications:

Masters degree and 1 to 3 years of Quality experience OR
Bachelors 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
Bachelors 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

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