Quality Assurance Manager

Kilitch Drugs; Khopoli; On-site; INR 900,000 - 1,400,000; Full time

Job summary

Kilitch Drugs in Maharashtra is seeking a Quality Assurance professional to ensure cGMP and regulatory compliance, review BMR/BPR, and approve the release of finished products. You will maintain documentation and SOP adherence, and coordinate with production and QC teams.

The role also oversees QMS activities including deviation management, OOS, CAPA and change control, drives continuous quality improvements, and handles regulatory, customer, and internal audits.

Qualifications

• Ensure strict cGMP and SOP adherence.
• Coordinate with Production, QC, and other departments.
• Drive continuous quality improvement initiatives.
• Handle regulatory, customer, and internal audits.

Responsibilities

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

Skills

cGMP

WHO-GMP

QMS

Deviation handling

OOS

CAPA

Change Control

Validation

Regulatory audits

Documentation

SOP compliance

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