Specialist QA
Amgen · Hyderabad, India
QualityFull-timeCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Amgen seeks a QA Specialist to manage product disposition activities across its global quality operations network in Hyderabad. The role involves overseeing expiry management, product complaints, partner data requests, and training disposition managers across multiple time zones.
What they're looking for
- Master's degree with 8-12 years pharma/biotech manufacturing quality experience
- Knowledge of GMP, GDP, and regulated environment compliance
- Proficiency with SAP, MES, LIMS, and quality management systems
- Experience training staff and developing technical documentation
- Strong verbal and written communication abilities
- Ability to lead cross-functional teams in fast-paced settings
What you'll be doing
- Execute GMP processes for product shelf-life extensions and expiration date updates in SAP
- Review and evaluate stability assessment forms for clinical and commercial product batches
- Support partner requests by retrieving and communicating batch data from multiple systems
- Generate and distribute Certificates of Analysis for drug substances and products
- Deliver quality systems training to disposition managers across the network
Privacy & handoff
This role links to Amgen's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.