Senior Executive In-Process Quality Assurance

Job Summary

The Senior Executive – Cell & Gene Therapy (CGT) Manufacturing is responsible for executing and monitoring CGT production activities in compliance with cGMP/cGTP requirements. The role ensures aseptic process adherence, real-time documentation, deviation reporting, and shopfloor regulatory compliance.

Key Responsibilities

Execute CGT manufacturing processes as per approved SOPs and batch records.

Perform line clearance and equipment readiness checks prior to batch initiation.

Ensure strict adherence to aseptic handling and sterile practices.

Maintain chain-of-custody traceability throughout the manufacturing lifecycle.

Complete real-time Batch Manufacturing Record (BMR) documentation accurately.

Ensure shopfloor compliance with cGMP and cGTP standards.

Identify, document, and report deviations as per QMS requirements.

Review batch records and manufacturing documents for accuracy and completeness.

Mandatory Qualifications & Skills

Strong knowledge of cGMP / cGTP guidelines

Hands-on experience in Cell & Gene Therapy manufacturing

Sound understanding of QMS, GDP, and Data Integrity principles

Experience in aseptic operations

Good communication and coordination skills

Ability to work effectively in regulated shopfloor environments

Preferred / Good to Have

Exposure to Process Validation and Cleaning Validation

Experience in APQR preparation

Knowledge of Environmental Monitoring & Contamination Control

Experience in documentation preparation and review