Data Integrity Specialist

DGXPComplianceLab; Hyderabad; On-site; INR 900,000 - 1,300,000; Full time

Job summary

DGXPComplianceLab seeks a Data Integrity Specialist to assess and strengthen data integrity across laboratory and manufacturing systems. You will perform data-integrity gap and risk assessments, review audit trails and configurations, and define remediation plans while training teams on ALCOA+ and good practices.

This role supports inspections and responses, requiring 4–9 years in QA/QC/CSV with regulatory guidance knowledge and experience with CDS/LIMS/MES.

Qualifications

• 4–9 years in QA, QC, CSV or compliance with data-integrity focus.
• Knowledge of MHRA, FDA and WHO data-integrity guidance.
• Experience with CDS, LIMS or MES.
• Structured reporting.

Responsibilities

• Assess and strengthen data integrity across laboratory and manufacturing systems.
• Perform data-integrity gap and risk assessments.
• Review audit trails and system configurations.
• Define remediation plans and controls.
• Train teams on ALCOA+ and good practices.
• Support inspections and responses.

Skills

QA/QC/CSV experience

Regulatory guidance

CDS/LIMS/MES

Structured reporting

Job description

Compliance & Regulatory Ref DGXP-JOB-2026-031 2 positions

Data Integrity Specialist

Assess and strengthen data integrity across laboratory and manufacturing systems.

• Perform data-integrity gap and risk assessments
• Review audit trails and system configurations
• Define remediation plans and controls
• Train teams on ALCOA+ and good practices
• Support inspections and responses

Required skills

• 4–9 years in QA, QC, CSV or compliance with data-integrity focus
• Knowledge of MHRA, FDA and WHO data-integrity guidance
• Experience with CDS, LIMS or MES
• Structured reporting

Preferred skills

• Experience remediating warning-letter or 483 observations