Quality Specialist in भारत

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.