Senior Executive
3xper Innoventure Limited · Tirupati · onsite · Posted 60d ago
About a minute. You'll make an account on the way through.
About this role
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.
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