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, flexible, 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, flexible, 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 Lead




Experience: 6 to 15 Years

Location: Noida

Roles and responsibilities:

• Good 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

• Valuable knowledge and experience in CSV

• Leading investigations for Quality issues identified internally or externally during Audits

📌 QA Lead (Noida)
🏢 Ydts Global
📍 Noida