17 Sep
|
Instrumentationntrol Solutions
|
Indore
17 Sep
Instrumentationntrol Solutions
Indore
> What We Offer
- Market-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.
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
📌 Senior CSV Consultant (Overseas) (Indore)
🏢 Instrumentationntrol Solutions
📍 Indore