CAPA and Quality Compliance Analyst

Capgemini

3–6 yrs Coimbatore Full Time Work from office
Capgemini logo
Posted : today
Actively hiring

Job description

Join Capgemini Engineering, a global leader in engineering services, and contribute to the success of innovative companies. We are seeking a skilled CAPA and Quality Compliance Analyst to support Life Sciences and Healthcare organizations in maintaining exceptional quality and regulatory adherence.

This role is crucial for ensuring the effectiveness of Corrective and Preventive Actions (CAPA), readiness for audits, and compliance with stringent industry standards. Become part of a team that drives continuous improvement and operational excellence in regulated environments.

Responsibilities

As a CAPA & Quality Compliance Analyst, you will manage the full CAPA lifecycle, ensuring adherence to quality and regulatory mandates. Your responsibilities will include:

- Supporting CAPA initiation, investigation, and closure processes. - Reviewing quality data and documentation for CAPA assessments. - Collaborating with stakeholders for investigations and remediation. - Facilitating root cause analysis, risk evaluations, and action planning. - Maintaining CAPA records and tracking overdue items. - Providing CAPA status reporting and escalating risks.

Qualifications

We are looking for candidates with:

- A Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Engineering, or a related field. - 3 to 6 years of experience in CAPA Management, Quality Compliance, or Quality Assurance. - Strong domain knowledge in Life Sciences or Medical industries. - Hands-on experience with Compliance, Regulatory Operations, and CAPA management. - Expertise in Root Cause Analysis, Risk Assessment, and Effectiveness Checks. - Familiarity with Quality Management Systems (QMS) and eQMS platforms like TrackWise Digital, Veeva Quality, or MasterControl. - Understanding of Data Integrity, Controlled Documentation, and Audit Readiness.

Essential Skills

CAPA ManagementQuality ComplianceRegulatory OperationsQuality AssuranceQuality SystemsRoot Cause AnalysisRisk AssessmentEffectiveness ChecksQuality Management Systems (QMS)Data IntegrityControlled DocumentationAudit ReadinessTrackWise DigitalVeeva QualityMasterControleQMS

Highlights

  • Actively hiring

More Details

RoleCAPA and Quality Compliance Analyst
IndustryHealthcare, Engineering
DepartmentQuality Assurance
Employment TypeFull Time, Work from office

About the Company

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Capgemini

Healthcare

CAPA and Quality Compliance Analyst at Capgemini | SkillMX | SkillMX