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:

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