About our client:

Our client brings together Pharmacovigilance expertise, third party system knowledge and Deep technology to develop well-defined solutions, which address challenges across Medical Affairs, Regulatory and Safety functions.

Our client solutions free up responsible personnel within Pharma companies to execute their stated responsibilities while staying true to the laws of the land, and ultimately achieving a balance between compliance and managing

business risks. Their solutions are agile, versatile, and scalable, developed using advanced technologies that enable them to serve large and small organizations, both in developed and emerging markets.

Our client is committed to bringing focus to things that really matter for advancing patient outcomes. Their solutions are agile, versatile, and scalable, developed using advanced technologies that enable us to serve large and small organizations, both in developed and emerging markets.

Requirements





Position Overview:

Title: QA LeadExperience: 6 to 15 Years

Location: Noida

Roles and responsibilities:
Valuable Knowledge of GAMP 5 guidelines
Quality Assurance experience
Experience of creating SOP/Policies/Guidelines/Procedures
Good knowledge of applicable regulations such as 21 CFR Part 11 and EU Annex 11
Experience in conducting Internal Audits
Experience of facing external audits
Experience and good understanding of regulations such as GDPR
Understanding of Data Privacy, Data Security
Knowledge and working experience on ISO 27001 and other standards
Experience on writing Deviations and CAPA
Managing IT GxP system compliance
Good knowledge and experience in CSV
Leading investigations for Quality issues identified internally or externally during Audits

📌 Qa Lead Pharmacovigilance Noida (India)
🏢 Ydts Global
📍 India