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Manager - QA

Manager - QA

GLOBAL CALCIUM

10 - 15 years

0 Lacs

Hosur Tamil Nadu India

Posted:1 day ago| Platform:

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Skills Required

management compliance documentation audits api manufacturing planning scheduling stability test data technology audit training coordination calibration monitoring

Work Mode

On-site

Job Type

Full Time

Job Description

Job Summary

Experienced Quality Assurance professional with a strong background in the

Active Pharmaceutical Ingredient (API)

industry. Responsible for implementing and maintaining

GMP-compliant Quality Management Systems

to ensure product quality, regulatory compliance, and operational excellence. Key responsibilities include managing documentation, handling audits (regulatory and customer), overseeing batch release, deviation investigations, and ensuring adherence to global regulatory standards (cGMP, ICH, FDA, etc.). The role demands expertise in validation, change control, and continuous quality improvement within a highly regulated API manufacturing environment.

Quality Planning and Scheduling
Implementation of QMS, GMP, cGMP, ISO, and Food Safety Standards
Compliance with Statutory and Regulatory Requirements
Document Management and Control
Review and Implementation of Quality System Procedures and SOPs
Batch Review, Approval, and Release
In-Process Control and Material Management
Review of Product Stability and Test Data
Handling of OOS, Deviations, and Batch Failures
New Product Technology Transfer
Internal, Vendor, and Customer Audit Handling
Annual Product Review
GMP and QMS Training Coordination
Validation and Calibration Programme Control
Quality Oversight and Continuous Compliance Monitoring

Qualification : B Pharma or MSc Chemistry
Experience : 10 to 15 YearsSkills: gmp,quality assurance,audit handling,quality management systems,change control,food safety standards,documentation management,iso,api manufacturing,compliance,validation,cgmp

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Manager - QA