Amgen Product Quality Specialist Role For Chemistry – Apply Online
Amgen – Product Quality Specialist
Location: Hyderabad, India
Job ID: R-202025
Work Location Type: On-Site
Category: Quality
Date Posted: November 26, 2024
About the Role
As a Product Quality Specialist, you will play a key role in ensuring the quality and safety of Amgen’s biologics or synthetic products. Collaborating with cross-functional teams, you will contribute to:
- Supporting Product Quality Teams (PQT) for late-stage or commercial programs.
- Authoring and reviewing GMP and regulatory documents.
- Managing product data, stability programs, periodic/annual product reviews (APR), and comparability assessments.
- Analyzing process and product quality data, including in-process, release, and stability data.
This position offers a chance to work on cutting-edge technologies and drive meaningful impact in product quality while addressing global healthcare challenges.
Responsibilities
- Execute and manage Product Quality strategies to achieve team goals.
- Support regulatory filing sections, respond to questions, and conduct risk-based evaluations of quality data.
- Operate and maintain proficiency in computer-based GMP Quality systems.
- Contribute to initiatives aimed at ensuring overall product health.
Basic Qualifications
- Doctorate Degree in chemistry, biochemistry, biology, or related fields + 2 years of experience in Quality, Operations, Scientific, or Manufacturing, OR
- Master’s Degree in the same fields + 6 years of relevant experience, OR
- Bachelor’s Degree in the same fields + 8 years of relevant experience.
Preferred Qualifications
Must-Have Skills:
- Proficiency in oral and written communication of complex technical information.
- Knowledge of cGMP and international regulatory standards.
- Strong data management and organization skills.
- Ability to meet project timelines using computer-based systems.
- Effective in building and maintaining cross-functional relationships.
Good-to-Have Skills:
- Experience working with global, virtual teams in a matrixed environment.
- Expertise in tools like Veeva, Spotfire, and SHINY.
- Proficiency in MS Office Suite (Word, Excel, PowerPoint, Teams).
Soft Skills:
- Analytical and problem-solving abilities.
- Self-motivation and initiative.
- Strong presentation and public speaking skills.
- Ability to manage priorities and respond to urgent requests effectively.
- Team-oriented and goal-focused mindset.
Why Join Amgen?
- Work at the interface of research, global development, and manufacturing.
- Contribute to innovative solutions in biologics and synthetics manufacturing.
- Help shape the future of healthcare by delivering high-quality medicines to patients worldwide.
Keywords: Amgen, Product Quality Specialist, Quality Control, Biologics, Synthetics, Regulatory Compliance, Pharmaceutical Sciences. Amgen Product Quality Specialist Role For Chemistry – Apply Online. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
