Quality Specialist

Quality Specialist This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Quality Specialist based in India. As a Quality Specialist, you will play a vital role in maintaining quality standards, regulatory compliance, and continuous improvement across healthcare and pharmaceutical-related operations. You will support the implementation and management of quality management systems, ensuring compliance with applicable Good Practice (GxP) guidelines and regulatory requirements. Your responsibilities will include managing deviations, quality events, corrective and preventive actions (CAPAs), and change control activities. You will also contribute to audit readiness, regulatory inspections, quality reporting, and root cause investigations to strengthen operational effectiveness. For medical information activities, you may evaluate telephone interactions and case reports to ensure adherence to established quality standards. This role offers the opportunity to collaborate with cross-functional teams and clients in a quality-focused environment that values precision, accountability, and continuous learning. You will help safeguard process integrity while supporting the delivery of reliable, high-quality services. Accountabilities Maintain awareness of applicable GxP guidelines and regulatory requirements, ensuring that quality processes and service delivery activities remain compliant with established standards. Support and coordinate electronic Quality Management System (eQMS) activities, including change control, deviations, quality events, CAPAs, and effectiveness checks. Develop, recommend, monitor, and document deviations, quality events, and corrective and preventive actions, ensuring appropriate root cause analysis and effective resolution. Review, approve, and communicate root cause investigation findings and CAPA plans to relevant stakeholders, ensuring clear documentation and accountability. Conduct effectiveness checks to verify that corrective and preventive actions have addressed identified issues and reduced the likelihood of recurrence. Participate in GxP change management activities, including risk and impact assessments, change plan reviews and approvals, implementation monitoring, and tracking actions through completion. Coordinate client audits and regulatory inspections, including preparing agendas, organizing required documentation, arranging logistics, and ensuring relevant subject matter experts are available. Coordinate audit-related CAPA responses, collaborating with internal stakeholders to prepare accurate, comprehensive, and timely responses. Maintain audit and inspection records in the eQMS, ensuring that documentation is complete, accurate, appropriately stored, and tracked through closure. Generate quality reports and analyze data related to deviations, quality events, CAPAs, and key performance indicators to identify trends, risks, and opportunities for improvement. Investigate quality issues, identify root causes, and recommend improvements to quality systems, procedures, and operational processes. For medical information quality assurance activities, retrospectively evaluate telephone interactions and case reports to verify compliance with applicable procedures and quality standards. Collaborate with internal teams, quality stakeholders, and clients to support continuous improvement, strengthen compliance, and maintain high service quality. Undertake additional quality-related responsibilities as needed to support evolving business and operational requirements. Requirements A bachelor's degree or equivalent relevant professional experience in a suitable discipline is required. 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 quality-related activities. Experience with quality management processes, including deviations, quality events, CAPAs, effectiveness checks, and change control, is preferred. Familiarity with electronic Quality Management Systems (eQMS), including quality record management, documentation, reporting, and data analysis. Strong understanding of root cause analysis, corrective and preventive action planning, risk assessment, and continuous improvement methodologies. Excellent organizational, prioritization, project management, and multitasking skills, with the ability to manage several activities and deadlines simultaneously. Exceptional attention to detail and a strong commitment to accuracy, documentation quality, and regulatory compliance. Proficiency in Microsoft Office applications, including Outlook, Word, Excel, and PowerPoint. Fluency in written and spoken English, with strong verbal, written, and interpersonal communication skills. Ability to build effective professional relationships with clients, internal teams, management, and cross-functional stakeholders. Strong customer service skills and a collaborative approach to resolving quality issues and supporting internal and external stakeholders. Ability to work independently with minimal supervision while remaining proactive, flexible, and responsive to changing priorities. A professional attitude, openness to change, and the ability to contribute positively to a diverse, collaborative, and quality-driven environment. Experience conducting Medical Information Quality Assurance reviews, particularly evaluating recorded telephone calls and case reports in a call center environment. Benefits Remote working opportunities in India, with potential hybrid arrangements for employees located within a reasonable commuting distance of an office, as agreed with their manager. Opportunities to strengthen expertise in quality assurance, GxP compliance, quality management systems, and regulatory processes. The opportunity to support quality and compliance activities that contribute to reliable healthcare and pharmaceutical services. Opportunities to work with cross-functional teams, subject matter experts, and clients on quality improvement initiatives. Exposure to audits, regulatory inspections, quality investigations, and process improvement activities. A commitment to diversity, equity, inclusion, and creating an environment where employees can contribute authentically and develop their skills. Opportunities to expand quality assurance expertise and take on additional responsibilities as business needs evolve. Jobgether