Quality Assurance Manager

2 weeks ago


Aligarh, Uttar Pradesh, India beBeeCompliance Full time ₹ 1,80,00,000 - ₹ 2,02,00,000

Job Overview

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  • Develop and implement quality audit processes to ensure compliance with GMP standards.
  • Maintain a robust document control system and establish a quality management system to manage change, deviations, incidents, and complaints.

Key Responsibilities

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  1. Lead cross-functional teams to ensure the company is ready for regulatory inspections, coordinate vendor qualification activities, and oversee investigations of non-conformances.
  2. Develop and implement batch release and reject systems, and work with the management team to stay abreast of changes in quality regulations and guidelines.
  3. Provide quality guidance to product development projects and programs, ensuring data integrity and adherence to regulatory requirements.
  4. Maintain departmental operational performance, develop SOPs, and ensure compliance with company policies and external requirements.

Additional Duties

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  • Prepare, review, and finalize documents for external customers and agencies, as well as managing validation master plans, control sample management, stability management, and artwork approval.
  • Ensure all activities are performed according to GMP, company SOPs, and health and safety policies, and establish a self-inspection program to meet EU GMP/PICS/TG/MHRA requirements.


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