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 :





- Strong 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 new 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