Mandatory Skills: (Must Have Skills) Strong hands-on experience in GxP / IT Validation (CSV / CSA) within regulated environments Solid knowledge of GAMP 5, CFR Part 11, EU Annex 11 and Novo Nordisk QMS Proven capability as Validation Responsible / Validation Lead for IT systems Experience in risk-based validation across Agile and V Model deliveries Hands on experience with Change, Incident, and Deviation Management (including RCA & CAPA) , Supplier assessment Working knowledge of tools such as ServiceNow, Veeva Vault / QualityDocs, and validation repositories Ability to author, review, and manage validation & compliance documentation Strong stakeholder collaboration and communication skills in a global setup Ability to work independently with a strong quality and compliance mindset
Mandatory Skills: (Must Have Skills) Strong hands-on experience in GxP / IT Validation (CSV / CSA) within regulated environments Solid knowledge of GAMP 5, CFR Part 11, EU Annex 11 and Novo Nordisk QMS Proven capability as Validation Responsible / Validation Lead for IT systems Experience in risk-based validation across Agile and V Model deliveries Hands on experience with Change, Incident, and Deviation Management (including RCA & CAPA) , Supplier assessment Working knowledge of tools such as ServiceNow, Veeva Vault / QualityDocs, and validation repositories Ability to author, review, and manage validation & compliance documentation Strong stakeholder collaboration and communication skills in a global setup Ability to work independently with a strong quality and compliance mindset
Mandatory Skills: (Must Have Skills) Strong hands-on experience in GxP / IT Validation (CSV / CSA) within regulated environments Solid knowledge of GAMP 5, CFR Part 11, EU Annex 11 and Novo Nordisk QMS Proven capability as Validation Responsible / Validation Lead for IT systems Experience in risk-based validation across Agile and V Model deliveries Hands on experience with Change, Incident, and Deviation Management (including RCA & CAPA) , Supplier assessment Working knowledge of tools such as ServiceNow, Veeva Vault / QualityDocs, and validation repositories Ability to author, review, and manage validation & compliance documentation Strong stakeholder collaboration and communication skills in a global setup Ability to work independently with a strong quality and compliance mindset
Source: HCLTech careers — Read the original posting and apply
This role is listed by the employer on its own careers site. Kaam Ki Khoj does not process applications for it.
HCLTech is an employer in the IT/Computers - Software, Software Services sector with operations in India. This is a directory listing maintained by Kaam Ki Khoj so that candidates can find the organisation; it is not an official company page and Kaam... Read More
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