Quality Assurance Professional

Job Title : Regulatory Compliance Specialist

Key Responsibilities :

• Conduct internal and external audits to verify adherence to regulatory standards and quality guidelines.
• Evaluate and maintain the company's quality management system (QMS). Review quality events, incidents, and complaints to identify root causes and recommend corrective and preventative actions (CAPAs).
• Prepare detailed audit reports documenting findings, non-conformities, and recommendations for improvement. Present these findings to senior management and work with teams to resolve issues.
• Stay up-to-date with applicable regulations and guidelines from bodies like the FDA and ICH. Ensure these regulatory requirements are communicated and implemented across the organization.
• Ensure training compliance of quality assurance procedures, GXP guidelines, and the importance of a quality-focused approach.

Required Skills and Qualifications :