Head of Quality Excellence

3 days ago

Kanpur, Uttar Pradesh, India beBeeQuality Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

Job Title: Quality Assurance Director

About the Role

The Company seeks an exceptional Quality Assurance Director to lead and manage its quality assurance function. This role is responsible for ensuring the Company maintains a state of readiness for inspection by regulatory agencies.

  • We are seeking a results-driven individual with experience in managing and leading cross-functional teams, implementing quality management systems, and ensuring compliance with cGMP regulations.
  • A strong understanding of GMP requirements and quality standards, including ICH Q8, Q9, and Q10, is essential.
  • The successful candidate will have excellent communication and interpersonal skills, as well as the ability to work collaboratively with various departments, including manufacturing, warehouse, and QC.
Responsibilities
  • Develop, implement, maintain, and improve quality audit and GMP quality systems.
  • Coordinate vendor qualification activities, internal audits, and compliance audits.
  • Manage Qualified Person audits and Regulatory Inspections.
  • CAPAs for all audits and inspections.
  • Develop and maintain document control systems.
  • Implement robust Quality Management Systems (QMS).
  • Lead trainings and quality training programs.
  • Oversee investigations of non-conformances.
  • Handle Product Recall.
  • Create and maintain system for ICH Q8, Q9, and Q10.
  • Ensure cGMP requirements and quality standards are recognized, understood, and maintained.
  • Develop batch Release and Reject system.
  • Work across disciplines to ensure readiness for inspections.
Requirements
  • Bachelor's degree in a scientific discipline or relevant field.
  • Minimum 5 years of experience in quality assurance or related field.
  • Strong knowledge of GMP regulations and industry practices.
  • Excellent leadership and communication skills.
  • Ability to work in a fast-paced environment.
What We Offer

The Company offers a competitive salary package, opportunities for career growth and development, and a dynamic work environment.

This role requires a self-motivated individual with a passion for quality and excellence.

Apply now to join our team

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