Senior Executive, Quality Control

Role Summary:

The position is responsible for the preparation, review, maintenance, and lifecycle management of QC master data in Caliber LIMS, ensuring compliance with approved specifications, GMP requirements, data integrity principles, and regulatory expectations. The role involves creating and reviewing product specifications, test methods, sampling plans, material masters, stability protocols, and workflow configurations within the LIMS environment. The position ensures accuracy, completeness, and consistency of master data to support laboratory operations, regulatory compliance, and audit readiness. The role collaborates with QC, QA, Manufacturing, and IT teams to implement system updates, troubleshoot issues, and drive continuous improvements in laboratory data management processes.

Essential Responsibilities:

• Prepare and maintain master data in Caliber LIMS as per approved procedures.
• Review and approve LIMS masters to ensure accuracy and compliance.
• Create and update specifications, test methods, sampling plans, products, materials, instruments, and user masters.
• Configure workflows and test templates based on approved quality documents.
• Ensure compliance with GMP, ALCOA+ principles, and Data Integrity requirements.
• Support change controls, deviations, CAPAs, and regulatory commitments related to LIMS.
• Perform periodic review and reconciliation of master data.
• Coordinate with QC, QA, and IT teams for system enhancements and issue resolution.
• Support internal audits, regulatory inspections, and customer audits.
• Maintain documentation related to master creation, review, approval, and version control.
• Provide user support and training on LIMS processes when required.

Essential Skills:

• Hands-on experience in Caliber LIMS master preparation and review.
• Strong knowledge of GMP, GLP, Data Integrity, and ALCOA+ principles.
• Understanding of QC laboratory workflows and pharmaceutical testing processes.
• Knowledge of specifications, STPs, sampling plans, and product lifecycle management.
• Experience in master data management and workflow configuration.
• Proficiency in handling change controls, deviations, and CAPA systems.
• Good documentation and technical writing skills.
• Strong analytical, troubleshooting, and problem-solving abilities.
• Effective coordination and communication skills.
• Proficiency in MS Office applications, especially Excel.

Preferred Qualification:

• B. Pharm / M. Sc. (Chemistry, Microbiology, Biotechnology, or related discipline)

Preferred Experience:

• Experience in QC-LIMS operations within a regulated pharmaceutical manufacturing environment (OSD/Injectable).
• Experience as Master Preparator and/or Reviewer in Caliber LIMS.

Education:

• Bachelors Degree (BA/BS) B. Sc. - Required
• Master Degree (MS/MA) M. Sc. - Preferred

Experience:

• 5 years or more in 7-10Years

Specialized Knowledge: Licenses: