Job Description

Company Description VasishthaCloud Pvt Ltd. is a solutions provider specializing in CRM implementation, data management, reporting, and analytics. The company\'s core expertise lies in providing these services to the Biotech, Pharmaceutical, and Life Sciences industries with a focus on small to medium-sized companies. The company operates remotely and can be contacted through their website or at [HIDDEN TEXT]. Role Description This is a full-time remote role for a Validation Lead. The Validation Lead will be responsible for Computer System Validation, Process Validation, Quality Control, Quality Assurance, and overall Validation plan/strategy. The Validation Lead will also work with cross-functional teams to ensure compliant documentation and assessments, while promoting and creating a culture of Quality. Responsibilities Hands-on delivery of quality practices based on industry standards, including identification, mitigation, and communication of risks with key stakeholders Analyze customer and business needs in determination of a validation strategy Develop and execute CSV documents: Validation Plans, User and Functional Requirements, Design Specifications, Risk Management Plans, Installation/Operational/Performance Qualification Protocols, Traceability Matrices, Final Reports, Deviation Handling Validation testing support (e.g., test plan authoring/support, manual test case execution, risk impact assessment, and quality education) Author and review SOP\'s Manage and support change control activities Client facing validation lead for the implementation of and support of computer systems Coordination with IT, Business, Regulatory Affairs, and Quality to develop, coordinate and execute Validation documents and strategies Responsible for the implementation and ongoing support of validated IT applications Drive project activities to completion Manage project deliverables Communicate risk, issues, and formulate viable mitigation plans Required Skills 3+ years of direct experience in the validation of computerized systems 5+ years of experience in validation, IT, quality assurance, quality control, biomanufacturing, clinical and/or regulatory operations Knowledge of the biotech/pharmaceutical industry and current approaches to GxP computer related systems validation Experience with electronic document management systems (e.g. documentum, Qumas, SharePoint, Veeva Vault, etc.); application development and lifecycle management (e.g. Client ALM, JIRA, etc.); and IT service management systems (e.g. ServiceNow, SAP Solution Manager, etc.) Experience working in a client facing IT/Validation role Must have good organizational, presentation, meeting facilitation and technical writing skills Good understanding of SDLC

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