About this role
Job Description:
The candidate should possess strong analytical knowledge in Quality Control, and he is responsible for Caliber LIMS–related activities and the effective functioning of the Laboratory Information Management System (LIMS) at the API manufacturing facility. The role ensures accurate master data management, system configuration, calibration and stability management, troubleshooting, and compliance with GMP, data integrity, and regulatory requirements.
Job Responsibilities:
- Preparation and maintenance of Caliber LIMS Masters for various products, materials, and instruments.
- Preparation and maintenance of calibration schedules in LIMS.
- Updating Caliber LIMS master data as and when required.
- Preparation of test data configuration plans in LIMS.
- Preparation of Stability Masters and Stability Protocols.
- Troubleshooting of LIMS-related issues.
- Handling Change Control activities related to LIMS.
- Providing LIMS classroom training to users and supporting system implementation.
Skills & Competencies
- Experience in Caliber LIMS master creation and maintenance (products, materials, instruments)
- Hands-on experience in calibration schedule preparation and management in LIMS
- Knowledge of stability management (stability masters and protocols)
- Understanding of GMP, GLP, and Data Integrity (ALCOA+) principles
- Experience in Change Control and deviation handling related to computerized systems
- Ability to perform Caliber LIMS troubleshooting and user support
- Good documentation skills aligned with regulatory and audit requirements
- Strong coordination and communication skills for cross-functional interaction
- Proficiency in MS Excel and basic computer applications
Other facts
About Amneal India
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is guided by a simple belief: essential medicines should be accessible to everyone. What began as a promise to deliver high-quality, affordable medicines has evolved into a diversified portfolio spanning complex generics and injectables, biosimilars, and specialty medicines, including more than 290 products, with scale and capabilities that help reach patients across the healthcare system while combining world-class precision with a deep sense of personal responsibility for every dose we deliver.
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What you'll do
- The Officer, Quality Control is responsible for managing Caliber LIMS-related activities and ensuring the effective functioning of the Laboratory Information Management System at the API manufacturing facility. This includes master data management, calibration schedules, troubleshooting, and compliance with regulatory requirements.
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