Quality Assurance 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 :

Bachelor’s or Master’s degree in Engineering or a related technical field.

10–15 years of experience in Quality Management within a manufacturing environment, preferably in the pharmaceutical or API sector.

Recruitment Training Consulting Proven expertise in implementing and improving QMS frameworks aligned with ISO and GMP standards.

Strong hands-on experience with API supplier audits and vendor compliance management.

Comprehensive understanding of ISO 9001, GMP, FDA, and other regulatory frameworks.

Lead Auditor Certification

is mandatory.

Strong leadership skills with the ability to manage cross-functional quality teams and influence strategic decision-making.

Excellent analytical, communication, and problem-solving abilities.