QA Lead (Pharmacovigilance)

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:

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

• Good knowledge and experience in CSV

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