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.
- 1015 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.
