Quality Assurance Manager

1. 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.

2. 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.

3. 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.

4. 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.

• Education: Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biotechnology, or a related field.
• Experience: 10-15 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.