Quality Assurance Manager for Vadodara

1 week ago

Vadodara, Gujarat, India Waymade PLC Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Audit Management

  • Plan, schedule, and coordinate supplier audits (API, CMO, intermediates, and service providers) in line with global quality standards.
  • Maintain supplier audit data, audit schedules, and audit tracking systems.
  • Manage pre-audit preparation, audit conduct, and post-audit follow-up activities.
  • Review and monitor CAPA (Corrective and Preventive Action) plans to ensure timely and effective closure.

  • Support internal and external audit readiness.

  • Supplier Oversight and Communication

  • Maintain consistent communication with Contract Manufacturing Organizations (CMOs), API suppliers, and other partners to ensure compliance with agreed quality standards.

  • Evaluate supplier performance and support supplier qualification and requalification processes.

  • Manage supplier documentation and ensure data integrity within the supplier management database.

  • Compliance and Quality Systems

  • Ensure adherence to GMP, GDP, and other relevant regulatory and corporate compliance requirements.

  • Identify and mitigate risks related to supplier quality and audit management.

  • Support deviation investigations, change controls, and quality risk assessments where applicable.

  • QTA (Quality Technical Agreement) and System Responsibilities

  • Lead and coordinate Quality Technical Agreement (QTA) drafting, review, and maintenance in alignment with corporate templates and regulatory expectations.

  • Manage the supplier module in TrakWise, ensuring data accuracy and timely updates.
  • Collaborate cross-functionally with global QA, procurement, and technical teams for seamless quality governance.

Qualifications and Experience:

  • Education: Bachelor's or Master's degree in Pharmacy, Chemistry, Biotechnology, or a related field.
  • Experience: 8-10 years of experience in quality assurance, compliance, or supplier audit management within the pharmaceutical or biopharmaceutical industry.
  • Strong understanding of GMP/GDP guidelines, quality systems, and regulatory expectations.
  • Experience with supplier audits, CAPA management, and QTA handling preferred.
  • Hands-on experience with electronic quality management systems (e.g., TrakWise, Veeva, or similar) is an advantage.

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