Senior CSV Consultant (Overseas)

Instrumentation And Control Solutions; Indore District; Vor Ort; INR 1.200.000 - 2.000.000; Vollzeit

Benefits dieser Stelle

PF

ESIC

Medical Insurance

Zusammenfassung

Instrumentation And Control Solutions in India is seeking a professional to execute end-to-end CSV validation for GxP computerized systems. The role requires preparing and reviewing URS, FS/DS, risk assessments, validation plans and IQ/OQ/PQ, with a focus on compliant documentation.

The candidate will perform risk-based validation, assist with deviations, CAPA and change controls, and participate in audit-trail reviews. Travel internationally and coordination with global clients are required.

Qualifikationen

• Must execute end-to-end CSV activities for GxP computerized systems.
• Must prepare/review URS, FS/DS, Risk Assessments, Validation Plans, IQ/OQ/PQ, RTM and Validation Reports.
• Must perform risk-based validation and GxP impact assessments.
• Support deviations, CAPA, change controls and audit-trail reviews.
• Ensure compliance with GAMP 5, 21 CFR Part 11, EU GMP Annex 11 and ALCOA+.

Aufgaben

• Execute end-to-end CSV activities for GxP systems.
• Prepare and review URS, FS/DS, risk assessments, validation plans and IQ/OQ/PQ.
• Perform risk-based validation and GxP impact assessments.
• Support deviations, CAPA, change controls and audit-trail reviews.
• Coordinate with QA, IT, engineering and external vendors on CSV activities.

Kenntnisse

End-to-end CSV validation

URS/FS/DS review

Risk assessments

IQ/OQ/PQ validation

CAPA & change controls

GxP compliance

GAMP 5 & 21 CFR Part 11

International client-facing

Travel internationally

LIMS/MES/SAP-ERP familiarity

Tools

LIMS

MES

SAP/ERP

QMS

DMS/EDMS

LMS

CDS

eBR

SaaS/Cloud apps

Jobbeschreibung

What We Offer:

• Competitive Salary as per industry standards
• PF, ESIC, Medical Accidental insurance
• Full time role

Key skill requirements:

• Execute end-to-end CSV activities for GxP computerized systems.
• Prepare/review URS, FS/DS, Risk Assessments, Validation Plans, IQ/OQ/PQ, RTM and Validation Reports.
• Perform risk-based validation and GxP impact assessments.
• Support deviations, CAPA, change controls and audit-trail reviews.
• Ensure compliance with GAMP 5, 21 CFR Part 11, EU GMP Annex 11 and ALCOA+.
• Coordinate with international clients, QA, IT, Engineering and system vendors.
• Support client audits and regulatory inspections.
• Experience with systems such as LIMS, MES, SAP/ERP, QMS, DMS/EDMS, LMS, CDS, eBR or SaaS/Cloud applications.
• Strong knowledge of CSV and pharmaceutical GxP requirements.
• Excellent English communication and documentation skills.
• Prior international client-facing/overseas project experience is mandatory.
• Willingness to travel internationally.