API Quality Systems Manager

Quality Assurance Manager - API

Title : Quality Assurance Manager - API (Lead Auditor Certification)

Location : Verna, Goa

Experience : 10 - 15+ years of experience in Quality Assurance (with API experience)

OVERVIEW

We are seeking an experienced and detail-oriented QMS Head to lead our Quality Management initiatives and ensure compliance with the highest manufacturing and regulatory standards. The ideal candidate will possess in-depth expertise in ISO, GMP, and API quality systems, with a proven ability to drive continuous improvement and foster a culture of quality excellence across all departments.

Key responsibilities :

• Develop, implement, and maintain the organization’s Quality Management System (QMS) in compliance with ISO, GMP, and other relevant manufacturing standards.
• Ensure full compliance with regulatory, statutory, and customer-specific quality requirements.
• Lead, mentor, and develop the QA / QC teams, fostering a culture of accountability, precision, and continuous improvement.
• Monitor and report on quality performance metrics, identifying trends and executing corrective measures where necessary.
• Conduct and manage internal audits, and coordinate external audits by customers, certification bodies, and regulatory agencies.
• Plan, conduct, and oversee API audits, ensuring supplier and process compliance with cGMP and industry standards.
• Manage and oversee Corrective and Preventive Actions (CAPA) related to process deviations and audit findings.
• Oversee all quality documentation and record management as per QMS requirements.
• Collaborate cross-functionally with Production, R&D, Maintenance, Procurement, and Supply Chain to embed quality standards at every stage.
• Lead risk assessments, process validations, and equipment verification to ensure compliance and operational efficiency.
• Stay updated on industry regulations, ISO and GMP guidelines, and quality best practices to align the organization with global standards.

Skills and Qualifications :