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Capgemini

Global consulting, technology services, outsourcing

Consumer Incident & Complaint Management Specialist

Regulatory & Quality (Life Sciences)Updated on Nov 14
Full-timeCoimbatore, Tamil Nadu, IndiaNo salary listedIn-person

About the Job

Requirements

  • Strong Life Sciences, Pharmaceutical, Biotechnology, Medical Device, Healthcare, or regulated industry domain knowledge.
  • Hands-on experience in Compliance, Regulatory Operations, Quality Assurance, Quality Systems, or regulated operational environments.
  • Working knowledge of Quality Management System principles, data integrity requirements, controlled documentation, audit readiness, and compliance procedures.
  • Experience handling complaint records, post-market quality cases, investigations, quality events, or case processing activities.
  • Two to five years of experience.

Responsibilities

  • Review consumer incident and product complaint records for completeness, accuracy, consistency, traceability, and required product information.
  • Validate complaint narratives, product details, traceability codes, issue categorization, attachments, and supporting documentation before downstream processing.
  • Manage assigned complaint queues, exception reports, aging records, and closure status while ensuring service-level agreement adherence.
  • Coordinate with intake teams, quality functions, business stakeholders, technical teams, and product owners for clarification and data correction activities.
  • Identify potential safety, quality, regulatory, or recurring product signals and escalate them through approved processes.
  • Maintain complaint records and supporting evidence within CID, complaint intake platforms, electronic Quality Management System systems, or approved repositories while complying with security and privacy requirements.
  • Prepare operational reports covering complaint volumes, quality trends, data integrity metrics, backlog status, key performance indicator and service-level agreement performance, and exception management.
  • Support investigations, corrective and preventive action activities, audit readiness programs, regulatory inspections, training initiatives, and process improvement projects.
  • Ensure adherence to Quality Management System requirements, controlled documentation practices, and data integrity standards.

About the Company

Capgemini

Global consulting, technology services, outsourcing

Capgemini provides consulting, technology services, and outsourcing to help organizations transform digitally. Its offerings include strategy and transformation consulting, system integration, application development, IT infrastructure management, and managed IT operations. It differentiates itself with a global presence in over 50 countries and a focus on applying AI, cloud, and cybersecurity to real business problems. Its goal is to help clients navigate digital transformation and improve efficiency and innovation through tailored, contract-based or managed services.

Company size
10,001+
Company stage
IPO
Headquarters
Paris, France
Founded
1967

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