Quality Assurance Manager

Kilitch Drugs; Navi Mumbai, Khopoli; On-site; INR 500,000 - 800,000; Full time

Job summary

Kilitch Drugs in Navi Mumbai, India is seeking a result-driven Quality Assurance professional to ensure regulatory compliance and smooth batch release in a fast-paced pharmaceutical environment.

You will coordinate with Production and QC, drive continuous quality improvements, and lead audits with customers and regulators, contributing to the site’s cGMP excellence.

Qualifications

• Ensure proper documentation and SOP compliance
• Coordinate with Production, QC, and other departments
• Drive continuous quality improvement initiatives
• Handle regulatory, customer, and internal audits

Responsibilities

• Ensure compliance with cGMP, WHO-GMP & regulatory requirements
• Review & approve BMR/BPR & release of finished products
• Manage QMS activities Deviation,OOS,CAPA, Change Control
• Oversee validation & qualification activities (process, cleaning, equipment)

Skills

cGMP knowledge

WHO-GMP knowledge

Regulatory compliance

Documentation

Job description

• Ensure compliance with cGMP, WHO-GMP & regulatory requirements
• Review & approve BMR/BPR & release of finished products
• Manage QMS activities Deviation,OOS,CAPA, Change Control
• Oversee validation & qualification activities (process, leaning,equipment)

Required Candidate profile

• Ensure proper documentation and SOP compliance
• Coordinate with Production, QC, and other departments
• Drive continuous quality improvement initiatives
• Handle regulatory, customer, and internal audits