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Manager - QA

10 - 15 years

30 - 35 Lacs

Posted:1 hour ago| Platform: Naukri logo

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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 Years

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Global Calcium
Global Calcium

Manufacturing

Mineral City

200 Employees

14 Jobs

    Key People

  • John Smith

    CEO
  • Jane Doe

    CFO

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