Job Summary
We are seeking a Quality Assurance Expert to lead our quality systems and ensure compliance with regulatory guidelines. The ideal candidate will have strong technical leadership skills and experience in quality assurance, validation, and compliance.
Key Responsibilities:
Quality Assurance & Compliance:
Ensure compliance with GMP (Good Manufacturing Practices), FDA, EMA, ICH, and other global regulatory guidelines. Develop, implement, and oversee quality systems related to validation, qualification, and change control. Serve as the primary QA contact for validation activities, ensuring proper documentation, execution, and review of validation protocols. Conduct internal audits and regulatory inspections to assess compliance with quality and validation requirements. Ensure that validation deviations, non-conformances, and CAPAs (Corrective and Preventive Actions) are effectively investigated and closed.
Validation & Qualification Management:
Lead the development and execution of IQ/OQ/PQ protocols for equipment, utilities, facilities, and computerized systems. Oversee process validation, cleaning validation, method validation, and continued process verification. Collaborate with other functional areas to ensure proper qualification of new and existing equipment. Establish validation master plans (VMPs) and maintain validation lifecycle management. Conduct risk assessments for validation and qualification activities using FMEA and other risk management tools.
Leadership & Cross-Functional Collaboration:
Provide technical leadership and mentorship to QA, validation, and production teams. Serve as a liaison between Quality, Manufacturing, Engineering, and Regulatory Affairs as required to ensure alignment on validation strategies. Train and educate staff on validation principles, regulatory expectations, and quality systems.
Documentation & Data Integrity:
Ensure accurate and complete documentation in compliance with Good Documentation Practices (GDP). Review and approve validation protocols, summary reports, and technical documents. Maintain data integrity standards and ensure compliance with 21 CFR Part 11 and Annex 11 for computerized system validation.
Root Cause & Risk Analysis:
Conduct root cause analysis (RCA) for deviations, non-conformances, and validation failures to implement effective corrective actions. Perform risk assessments and apply risk management tools (e.g., FMEA, HACCP) to proactively identify and mitigate potential quality and compliance risks. Lead CAPA investigations and track implementation of preventive measures to enhance operational quality and regulatory compliance.