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 :
Valuable documentation skills aligned with regulatory and audit requirements :




Solid coordination and communication skills for cross-functional interaction

Qualification :
M.Sc. in Chemistry
4 to 6 years of relevant experience in Quality Control, preferably in LIMS administration within an API / Pharmaceutical manufacturing environment

Additional Responsibilities
Ensure timely updates of Caliber LIMS masters as per approved change controls
Support regulatory audits and inspections by providing LIMS-related documentation and explanations
Conduct classroom and hands-on LIMS training for QC users and current joiners
Assist in user access management and periodic review of LIMS roles and privileges
Participate in system validation, revalidation, and periodic reviews of LIMS
Ensure data integrity compliance and adherence to SOPs related to computerized systems
Coordinate with IT, QA, and external vendors for system enhancements and issue resolution
Support continuous improvement initiatives related to laboratory systems and processes

📌 Officer, Quality Control Visakhapatnam
🏢 Amneal Pharmaceuticals
📍 Visakhapatnam