Head of Quality Assurance

1 day ago

Mumbai, Maharashtra, India beBeeQuality Full time ₹ 18,75,000 - ₹ 23,10,000

Job Summary:

We are seeking a skilled Quality Assurance Head to lead our quality management systems and ensure compliance with regulatory requirements. As a key member of our team, you will establish quality goals, policies, and procedures, manage internal and external audits, and maintain ISO certifications.

Key Responsibilities:

  • Develop and maintain the company's Quality Management System (QMS) ensuring compliance with ISO, GMP, GDP, and Indian regulatory requirements.
  • Establish quality goals, policies, SOPs, and procedures for the organization.
  • Manage internal and external audits, ensure ISO certifications are maintained.
  • Approve and review documentation such as SOPs, WI, templates, and batch-related documents.
  • Monitor and improve CAPA systems, change controls, deviation handling, and complaint investigations.
  • Support QA teams at multiple sites for technical queries and compliance-related issues.

Manufacturing Oversight:

  • Ensure quality compliance of manufacturing, labelling, warehousing, and logistics activities.
  • Verify batch records, COAs, and distribution records are complete and compliant.
  • Maintain Good Distribution Practices (GDP) and infrastructure safety.

Leadership & Training:

  • Lead and mentor QA and EHS teams across locations.
  • Train staff on ISO, GMP, and safety standards.
  • Provide regular reports to management on system performance and improvement actions.
  • Promote a culture of quality, safety, and continuous improvement.

Requirements:

  • Bachelor's or master's degree in pharmacy, Life Sciences, or related field.
  • Certification in ISO 9001, ISO 13485, ISO 45001, ISO 14001, ISO 27001, CDSCO is mandatory.
  • Strong leadership, audit management, and team development skills.
  • Excellent communication, documentation, and problem-solving abilities.

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