Job Description
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
Qualification
QUALIFICATIONS
- 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
