Senior Executive

3xper Innoventure Limited; Tirupati; On-site; INR 600,000 - 900,000; Full time

Job summary

3xper Innoventure Limited in Tirupati, India, seeks a Senior Executive CSV/Quality Compliance with about 3 years in regulated pharma/CRO/CDMO environments to focus on CSV documentation review, data integrity, and audit readiness.

You will review URS, validation docs, ensure compliance with GAMP 5, 21 CFR Part 11, EU Annex 11, support audits and CAPAs, and coordinate with QA/IT/QC to close gaps. M.Pharm or MSc encouraged.

Qualifications

• 3+ years in CSV/QA/Quality Compliance in pharma/CRO/CDMO.
• Knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11 and Data Integrity.

Responsibilities

• Review CSV documents (URS, Risk Assessments, Validation Plans, IQ/OQ/PQ, Traceability Matrix, Validation Reports).
• Assess compliance of computerized systems with regulatory requirements.
• Support periodic review, change control, deviation and CAPA activities.
• Assist internal, customer and regulatory audits; prepare and review CSV evidence.
• Identify compliance gaps and coordinate with QA/IT/QC to close them.
• Maintain CSV/quality documentation and trackers.
• Exposure to QC lab systems (LIMS, CDS/Empower) is an advantage.

Skills

Documentation review

Audit coordination

Analytical skills

Cross-functional collaboration

Communication

Education

M.Pharm / M.Sc

Tools

LIMS

CDS/Empower

Job description

Senior Executive CSV / Quality Compliance

Experience: 3+ Years

Industry: Pharmaceutical / CRO / CDMO / Life Sciences

About the Organization

A leading Contract Research, Development and Manufacturing Organization (CRO/CDMO) serving pharmaceutical, biotechnology and life-sciences companies, with capabilities across research, process development and manufacturing.

Role Overview

We are looking for a Senior Executive CSV with around 3 years of experience in a regulated pharmaceutical/CRO/CDMO environment. The role will primarily focus on CSV documentation review, computerized system compliance, audit readiness and quality review, rather than being a pure CSV execution role.

Key Responsibilities

• Review CSV documents such as URS, Risk Assessment, Validation Plans, IQ/OQ/PQ, Traceability Matrix and Validation Reports.
• Review computerized systems for compliance with GAMP 5, 21 CFR Part 11, EU Annex 11 and Data Integrity/ALCOA+ requirements.
• Support periodic review, change control, deviation and CAPA activities related to computerized systems.
• Support internal, customer and regulatory audits, including preparation and review of CSV-related evidence.
• Identify compliance gaps and coordinate with QA, IT, QC and system owners for closure.
• Review and maintain CSV/quality documentation and trackers.
• Exposure to QC laboratory systems such as LIMS, CDS/Empower and computerized analytical instruments will be an advantage.

Candidate Profile

• M.Pharm / M.Sc
• Around 3 + years of experience in CSV / QA / Quality Compliance within Pharma/CRO/CDMO.
• Good understanding of GAMP 5, 21 CFR Part 11, EU Annex 11 and Data Integrity.
• Strong documentation review, analytical and audit-support skills.
• Good communication and cross-functional coordination skills.