CAPA and Quality Compliance Analyst at Capgemini Engineering in Coimbatore
Capgemini Engineering is hiring a CAPA and Quality Compliance Analyst in Coimbatore for candidates with 2+ years of experience. This Capgemini CAPA analyst role supports Life Sciences and Healthcare quality and regulatory compliance.
Job Details
Company: Capgemini Engineering
Location: Coimbatore
Experience: 2+ years
Job Description
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.
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.
Capgemini CAPA Analyst Key Responsibilities
- 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.
Required Skills for the Capgemini CAPA Analyst Role
- 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).
Additional Information
What You’ll Love About Working Here
- Work with leading global Life Sciences and Healthcare clients as a Capgemini CAPA analyst.
- 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.
How to Apply
About Capgemini Engineering
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 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.
CLICK HERE FOR THE ORIGINAL NOTIFICATION / APPLY ONLINE
To join as a Capgemini CAPA analyst, apply through the link above or the “Apply for this job” link in the How to Apply section.