Senior Quality Manager

1 day ago

Lucknow, Uttar Pradesh, India beBeeQuality Full time ₹ 30,00,000 - ₹ 50,00,000
Job Overview

Key Responsibilities:

  • Establish and maintain a robust quality audit process, ensuring adherence to GMP guidelines.
  • Coordinate vendor qualification activities, encompassing raw materials, packing materials, quality control laboratories, and outsourced services.
  • Perform Qualified Person audits and Regulatory Inspections, guaranteeing compliance with regulatory requirements.
  • CAPA close out for all audits and inspections, ensuring timely resolution of findings.
  • Develop and implement a GMP-compliant document control system, streamlining document management processes.
  • Design and execute a Quality Management System (QMS) to manage change management, deviation management, incidents, complaint handling, and CAPA management.
  • Provide quality guidance to product development projects, leveraging expertise in cGMP regulations.
  • Ensure Data Integrity through Internal Audits, Training, Review, and Reporting.
  • Maintain operational performance to meet regulatory authorities' expectations.
  • Develop, maintain, and approve SOPs to ensure regulatory compliance.
  • Adhere to GMP, company policies, and Health and Safety standards.
  • Organize review meetings and document corrective measures implemented for cGMP requirements.
  • Monitor IPQA activities and review reports, ensuring continuous improvement.

Requirements:

  • Knowledge of cGMP regulations and guidelines.
  • Experience in Quality Assurance or related field.
  • Strong leadership and communication skills.

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