CAPA and Quality Compliance Analyst

Capgemini Engineering; Coimbatore District; In loco; INR 600.000 - 900.000; Tempo pieno

Descrizione del lavoro

Capgemini Engineering in Coimbatore seeks a CAPA & Quality Compliance Analyst to support end-to-end CAPA processes, investigations, and action tracking within regulated Life Sciences environments.

You will collaborate with cross-functional teams, maintain CAPA records, and provide status reporting to stakeholders, contributing to quality transformation and regulatory readiness across projects.

Competenze

• 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).

Mansioni

• 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, elevate risks, and provide CAPA status reporting.

Formazione

Bachelor's degree in Life Sciences / Pharmacy / Biotechnology / Microbiology / Medical Sciences / Engineering / Quality Management

Strumenti

TrackWise Digital

Veeva Quality

MasterControl

eQMS

Descrizione del lavoro

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 mostinnovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as theyprovide 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 arethe 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, elevate 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 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.

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 mostinnovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as theyprovide 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 arethe same.