QA Lead

2 days ago


uttar pradesh, India YD Talent Solutions Full time

About our client:Our client brings together Pharmacovigilance expertise, third partysystem knowledge and Deep technology to develop well -defined solutions, whichaddress challenges across Medical Affairs, Regulatory and Safety functions. Ourclient solutions free up responsible personnel within Pharma companies toexecute their stated responsibilities while staying true to the laws of theland, and ultimately achieving a balance between compliance and managingbusiness risks. Their solutions are agile, flexible, and scalable, developedusing advanced technologies that enable them to serve large and smallorganizations, both in developed and emerging markets.Our client is committed to bringing focus to things that really matterfor advancing patient outcomes. Their solutions are agile, flexible, andscalable, developed using advanced technologies that enable us to serve largeand small organizations, both in developed and emerging markets.RequirementsPosition Overview: Title: QA Lead Experience: 6 to 15 YearsLocation: 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


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