Quality Assurance Manager

7 days ago

Mormugao, India HR Yaar Full time

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.

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