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Amgen Inc
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Product Quality Specialist

Product Quality Specialist

Amgen Inc

2 - 7 years

5 - 8 Lacs

hyderabad

Posted:1 day ago| Platform:

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Skills Required

data management computer application regulatory presentation skills cgmp python sas spotfire machine learning veeva sql quality systems microsoft teams data science product quality predictive modeling manufacturing statistical modeling statistics

Work Mode

Work from Office

Job Type

Full Time

Job Description

This role will support one or more late-stage and/or commercial biologics or synthetics products. The individual will provide project support to the relevant Product Quality Team (PQT) to implement and manage strategy for Quality to meet the Product Quality goals. The individual will be directly responsible for Product Quality related tasks including authoring and review of GMP and regulatory documents, execution of transactions in relevant GMP systems (document management system, complaint resolution system, data systems), and product data management, including stability, comparability assessments, periodic and annual product reviews (APR). In addition, the candidate will be expected to play a role in supporting Product Quality initiatives intended to ensure the overall product health.

Support PQ work for late-stage and/or commercial biologic or synthetic programs, including actions required for the PQT, APR, specifications, comparability, stability programs, and PQ owned regulatory filing sections and responses to questions (RTQ)
Support science and risk-based evaluation of complex process and product quality data such as in-process, release and stability data, complaints, method performance etc.

What we expect of you

Basic Qualifications and Experience:

Doctorate degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field & 2 years of Quality, Operations, Scientific, or Manufacturing experience, or
Masters degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field & 6 years of Quality, Operations, Scientific, or Manufacturing experience, or
Bachelors degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field & 8 years of Quality, Operations, Scientific, or Manufacturing experience or

Preferred Qualifications:

Must-Have Skills:

Demonstrate proficiency in oral and written communication of complex information to Product Quality team members and peers
Demonstrate proficiency in knowledge of cGMP and international regulatory expectations
Strong scientific data management and organization skills with attention to detail
Ability to deliver high quality results and adhere to project timelines using computer-based GMP Quality systems
Ability to build and maintain multi-functional relationships and strong partnerships through written and verbal communication skills

Good-to-Have Skills:

Experience working virtually on a multi-functional team in a matrix environment across multiple time zones
Expertise in computer applications such as Veeva, Spotfire, SHINY
Expertise in MS Office (Word, Excel, PowerPoint, MS Teams)

Soft Skills:

Analytical and problem-solving skills
Ability to work effectively with global, virtual teams
High degree of initiative and self-motivation
Ability to manage multiple priorities successfully, react quickly to address urgent requests and meet challenging timelines
Team-oriented, with a focus on achieving team goals
Strong presentation and public speaking skills

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Product Quality Specialist