
Validation Specialist
4 weeks ago
We are looking for an experienced
GxP Validation Specialist
to join our Quality & Compliance team in Gurgaon. The ideal candidate will have strong expertise in
GxP system validation, computer system validation (CSV), and regulatory compliance
, ensuring adherence to industry standards (FDA, EMA, GAMP 5). This role requires hands-on validation experience, attention to detail, and excellent communication skills.
Key Responsibilities
- Perform
end-to-end validation activities
for GxP-regulated systems, including Computer System Validation (CSV). - Prepare and review validation deliverables such as
URS, FS, DS, IQ, OQ, PQ, traceability matrix, and validation summary reports
. - Ensure compliance with
21 CFR Part 11, Annex 11, GAMP 5, FDA, and other global regulatory requirements
. - Collaborate with IT, QA, and business teams to plan, execute, and document validation activities.
- Support periodic reviews, audit readiness, and remediation activities for validated systems.
- Maintain validation documentation in accordance with
SOPs and quality standards
. - Provide support during
internal/external audits and inspections
.
Required Skills & Qualifications
- 5+ years
of experience in
GxP system validation / CSV
. - Strong knowledge of
regulatory guidelines (21 CFR Part 11, Annex 11, GAMP 5, FDA, EMA, ICH, MHRA)
. - Hands-on experience in preparing and reviewing
validation protocols and reports
. - Familiarity with
ERP, LIMS, MES, Laboratory Instruments, or other GxP systems
. - Excellent written and verbal communication skills.
- Strong analytical, documentation, and problem-solving abilities.
Good to Have
- Experience in
pharmaceuticals, life sciences, or medical devices
domain. - Knowledge of
risk-based validation approach
. - Exposure to
cloud-based GxP systems
. - Familiarity with
21 CFR Part 820 (QSR)
or ISO 13485.
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