At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world's most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D; and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same.

Job Description

CAPA & Quality Compliance Analyst

Location :- Coimbatore
Experience :- 2+ years

Choosing Capgemini Engineering means joining a team that supports global Life Sciences and Healthcare organizations in maintaining quality excellence, regulatory compliance, and continuous improvement across regulated operations. You will play a critical role in ensuring CAPA effectiveness, audit readiness, and compliance with industry standards.

Your Role

As a CAPA & Quality Compliance Analyst, you will support the end-to-end Corrective and Preventive Action (CAPA) process, ensuring compliance with quality management systems and regulatory requirements. You will collaborate with cross-functional stakeholders to manage investigations, root cause analysis, action tracking, effectiveness checks, and quality documentation within regulated Life Sciences environments.

In this role, you will:

- Support the CAPA lifecycle from initiation through closure in accordance with quality and regulatory requirements.
- Compile and review quality data, evidence, and documentation to support CAPA assessments and approvals.
- Coordinate with CAPA owners,



quality teams, SMEs, and business stakeholders throughout investigations and remediation activities.
- Facilitate impact assessments, root cause investigations, risk evaluations, and corrective/preventive action planning.
- Maintain CAPA records, action plans, approvals, due dates, and supporting evidence within TrackWise Digital or other approved eQMS platforms.
- Track open actions, monitor overdue items, escalate risks, and provide CAPA status reporting.

Mandatory Skills

- Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Microbiology, Medical Sciences, Engineering, Quality Management, or a related discipline.
- 3-6 years of experience in CAPA Management, Quality Compliance, Regulatory Operations, Quality Assurance, or Quality Systems.
- Strong Life Sciences / Medical Domain knowledge with experience in regulated industries.
- Hands-on experience in Compliance or Regulatory Operations.
- Experience managing CAPA, Deviations, Non-Conformances, Investigations, and Corrective & Preventive Actions.
- Strong expertise in Root Cause Analysis, Risk Assessment, and Effectiveness Checks.
- Working knowledge of Quality Management Systems (QMS), Data Integrity, Controlled Documentation, and Audit Readiness.




- Experience with TrackWise Digital, Veeva Quality, MasterControl, or other Electronic Quality Management Systems (eQMS).

What You'll Love About Working Here

- Work with leading global Life Sciences and Healthcare clients.
- Exposure to enterprise quality systems and regulatory compliance frameworks.
- Opportunities to contribute to quality transformation and continuous improvement initiatives.
- Access to learning platforms, industry certifications, and career development programs.
- Collaborative environment focused on innovation, quality, and operational excellence.

About Us

At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world's most cutting-edge companies unleash their potential. From life sciences and healthcare to advanced engineering and digital transformation, we provide unique R&D; and engineering services across industries. Join us for a career full of opportunities where you can make a difference every day.

At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world's most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D; and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same.

📌 CAPA and Quality Compliance Analyst (Coimbatore)
🏢 Capgemini
📍 Coimbatore