Assistant General Manager, Quality Control

Description:

To lead the Chemical Quality Control function at the injectable manufacturing site, ensuring timely, accurate, and compliant testing of raw materials, in-process samples, finished products, stability samples, and cleaning validation samples. The role ensures strict adherence to regulatory standards, drives data integrity, and maintains the readiness of the QC Chemical lab for inspections and audits.

Essential Functions:

• To Manage the QC Chemical laboratory operations including wet chemistry, instrumental analysis (HPLC, GC, UV, IR, etc.), and stability studies.
• Ensure efficient resource utilization and timely release of test results as per business requirements.
• Ensure all QC chemical activities are performed in compliance with cGMP, GLP, and data integrity standards.
• Review and approve test procedures, specifications, analytical methods, and associated documentation.
• Lead the investigation of OOS, OOT, deviations, and implement effective CAPAs.
• Ensure proper maintenance, qualification, and calibration of analytical instruments.
• Oversee the lifecycle management of equipment including procurement, validation, and decommissioning.
• Lead and mentor a team of QC Chemists and Analysts, ensuring continuous development and training.
• Conduct periodic performance reviews and skill-gap analysis to strengthen team capabilities
• Ensure the QC Chemical lab is always in a state of readiness for regulatory and customer audits.
• Represent the QC Chemical function during audits and ensure timely closure of observations related to chemical testing.
• Support technology transfers, method validations, cleaning validations, and new product introductions from the chemical testing perspective.
Coordinate with QA, RA, Production, and other functions for seamless quality operations.

Additional Responsibilities:

Lead and oversee all Quality Control (QC) activities for API manufacturing.

Act as QC Lead , providing strategic direction and technical leadership to the QC team.

Ensure compliance with cGMP, regulatory guidelines, and data integrity requirements .

Review and approve analytical results, OOS/OOT investigations, and CAPAs.

Manage QC documentation, SOPs, validation, and change control activities.

Coordinate with QA, Production, Engineering, and Regulatory teams.

Support internal, customer, and regulatory audits/inspections as the QC Lead representative .

Drive continuous improvement, team capability building, and performance management.

Education:

• Bachelors Degree B. Pharma - Required

• Master Degree M. Sc - Required
  

Experience:

• 15 years or more in 15 - 20 Years

Skills:

• Laboratory Data Management - Advanced
• Stability Study Documentation - Advanced
• Specifications & Test Methods Documentation - Advanced
• Analytical Method Validation Documentation - Advanced
• CAPA, Deviation, and Change Control Management - Mastery
• Training and Compliance Record Management - Advanced
• Knowledge of Regulatory guidelines/Requirement - Mastery
• Analytical evalution of vendor - Advanced
• Method Validation/verification Protocol Design/review - Advanced
• GMP Compliance for Environmental Monitoring - Mastery
• Documentation & Data Integrity Practitioner - Mastery
• CAPA, Deviation, and Change Control Management - Advanced
• Specifications & Test Methods Documentation - Advanced