Amgen Biology Jobs – Biochemistry Apply For Product Specialist Role
Product Quality Specialist
Location: India – Hyderabad
Job ID: R-202023
Work Location Type: On-Site
Category: Quality
Date Posted: Nov. 26, 2024
Product Quality Specialist
What You Will Do
Amgen invites you to join us in making a difference. As a Product Quality Specialist, you will provide technical expertise and leadership within the Product Quality (PQ) organization. This role involves collaboration with cross-functional teams, including Product Quality Leaders (PQL), International Distribution Quality, Quality Control, Regulatory, Process Development, and Quality Assurance.
Key responsibilities include:
- Supporting product specifications, in-process controls, periodic and annual product review, and complaint resolutions.
- Working on late-stage and/or commercial biologic or synthetic programs.
- Authoring and reviewing GMP and regulatory documents.
- Executing transactions in GMP systems (e.g., document management, complaint resolution, and data systems).
- Managing product data, including stability and comparability assessments and annual product reviews (APR).
- Contributing to Product Quality initiatives to ensure overall product health.
- Performing science and risk-based evaluations of complex process and product quality data.
What We Expect of You
Basic Qualifications and Experience:
- Doctorate in chemistry, biochemistry, biology, or a related field with 2 years of Quality, Operations, Scientific, or Manufacturing experience.
- Master’s degree in the same fields with 6 years of relevant experience.
- Bachelor’s degree in the same fields with 8 years of relevant experience.
Must-Have Skills:
- Proficiency in oral and written communication of complex information.
- Knowledge of cGMP and international regulatory expectations.
- Strong scientific data management and organizational skills with attention to detail.
- Ability to meet project timelines using computer-based GMP Quality systems.
- Proven ability to build relationships and communicate effectively.
Good-to-Have Skills:
- Experience working virtually in a matrix environment across time zones.
- Expertise in applications such as Veeva, Spotfire, and SHINY.
- Proficiency in MS Office (Word, Excel, PowerPoint, MS Teams).
Soft Skills:
- Analytical and problem-solving abilities.
- Effectiveness in global, virtual team environments.
- Initiative, self-motivation, and multitasking skills.
- Strong public speaking and presentation abilities.
- Team-oriented mindset focused on achieving shared goals.
At Amgen, you’ll be at the forefront of innovation, contributing to the transformation of molecules into life-changing medicines. Join us to make an impact and help shape the future of healthcare.
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