Quality Assurance Manager

6 days ago

Vizag, Andhra Pradesh, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 20,00,000

Job Summary:

A highly skilled Quality Assurance Leader is required to oversee the development and implementation of quality audit systems, maintain GMP standards, and ensure compliance with regulatory requirements.

Key Responsibilities:

  • Develop, implement, maintain, and improve quality audit systems and GMP standards
  • Coordinate and perform all vendor qualification activities for raw materials, packing materials, quality control external testing laboratories, and other outsourced activities
  • Responsible for Qualified Person audits and Regulatory Inspections
  • Develop and maintain a GMP compliant document control system
  • Establish a robust Quality Management System (QMS) to manage change management, deviation management, incidents, complaint handling, and CAPA management
  • Oversee investigations of non-conformances and handle product recalls
  • Create and maintain systems to implement ICH Q8, ICH Q9, and ICH Q10
  • Ensure cGMP requirements and quality standards are recognized, understood, and maintained across the organization
  • Work across all disciplines to ensure a state of readiness for inspection by regulatory agencies
  • Lead and manage training programs, provide quality guidance to product development projects, and ensure data integrity
  • Maintain and improve departmental operational performance to meet regulatory requirements and organizational SOPs

Requirements:

  • Well-versed in requirements of injectable products, facility requirements, and media fill requirements
  • Experience in developing and implementing quality audit systems, maintaining GMP standards, and ensuring regulatory compliance
  • Strong leadership and management skills, with the ability to train and guide team members
  • Excellent communication and problem-solving skills
  • Ability to work in a fast-paced environment and prioritize tasks effectively

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