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Senior Quality Assurance Manager

1 month ago

Ahmedabad, Gujarat, India Biotech Healthcare Full time
Job Title: Assistant General Manager QA

Job Summary:

We are seeking a highly skilled and experienced Quality Assurance professional to join our team at Biotech Healthcare. The successful candidate will be responsible for developing, implementing, and maintaining our Quality Management System (QMS) to ensure compliance with regulatory requirements.

Key Responsibilities:

  • Design, develop, and implement QMS systems to ensure compliance with regulatory requirements.
  • Authorize SOPs and master documents, including specifications, test procedures, and validation protocols.
  • Ensure procedure compliance for QMS systems, including CCN, deviation, market complaint, OOS, and CAPA.
  • Approve responsible and quality-related customer complaint investigations and trending activities.
  • Lead quality-based projects and conduct self-inspections and audits as required.
  • Support and maintain business continuity management plans.
  • Conduct training to all department personnel on GMP, GDP, routine validation, and in-process checks activities.

Requirements:

  • Minimum of 18 years of experience in Quality Assurance within the medical device industry.
  • Strong understanding of regulatory requirements, including FDA and ISO 13485.
  • Detail-oriented and highly skilled individual with excellent communication and leadership skills.

About Biotech Healthcare:

Biotech Healthcare is an Equal Opportunity Organization promoting diversity and ensuring no discrimination on any ground. We are committed to providing a safe and inclusive work environment for all employees.