Location: Indore (M.P)
Qualification: Bachelor’s/Master’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, Biotechnology, Engineering, IT, Computer Science or related discipline.
Experience: 4-10 Year
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.
Apply Now: hr@ics-india.co.in/shivani.kumawat@ics-india.co.in
Share your resume at: 9109188709/ 9109188512
