Quality Assurance Expert

Job Description

• Prepare and complete quality documentation, meet professional QA objectives provide reports on a regular basis, and have experience in self-inspections internal and external audits.
• Develop, periodic review, revise, and implement SOPs and other documents needed in different processes.
• Assist in the investigation process and define optimized process work.
• Follow priorities in order to implement corrective and preventive actions.
• Quality risk management.
• Apply CAPAs or change management.
• Participate in corporate meetings to support strategies, for meeting changing regulatory requirements and driving projects across the operations to implement required changes efficiently and effectively.
• Apply principles of continuous improvement.
• Apply and ensure implementation of standardized operating procedures.
• Approve documents according to templates and required GMPs, ISO IMS, etc.
• Assess audit findings.
• Provide inspectors with clear and comprehensive files (external audits).
• Respond with proficiency to questions from inspectors (external and internal audits).
• Periodic GMP training for relevant staff.
• Analyze, monitor, and ensure that the organization's processes comply with international standards.
• Liaise with customers and regulatory authorities regarding quality matters, including hosting inspections and responding to observations.