Quality Specialist

📋 Description

• Maintain awareness of applicable GxP guidelines and regulatory requirements, ensuring that quality
• Support and coordinate electronic Quality Management System (eQMS) activities, including change
• Develop, recommend, monitor, and document deviations, quality events, and corrective and preventive
• Review, approve, and communicate root cause investigation findings and CAPA plans to relevant
• Conduct effectiveness checks to verify that corrective and preventive actions have addressed
• Participate in GxP change management activities, including risk and impact assessments, change plan

🎯 Requirements

• A bachelor's degree or equivalent relevant professional experience in a suitable discipline is
• At least 2 years of professional experience in a Quality Assurance role.
• Working knowledge of GxP quality management systems and the regulatory requirements applicable to
• Experience with quality management processes, including deviations, quality events, CAPAs
• Familiarity with electronic Quality Management Systems (eQMS), including quality record management
• Strong understanding of root cause analysis, corrective and preventive action planning, risk

🎁 Benefits

• Flexible working arrangements: Remote working opportunities in India, with potential hybrid
• Professional development: Opportunities to strengthen expertise in quality assurance, GxP
• Meaningful contribution: The opportunity to support quality and compliance activities that
• Collaborative environment: Opportunities to work with cross-functional teams, subject matter
• Continuous learning: Exposure to audits, regulatory inspections, quality investigations, and
• Inclusive workplace: A commitment to diversity, equity, inclusion, and creating an environment