Craig Chastain
Computer System Validation Csa Gxp Clinical Systems at Blueprint Medicines
Based in Savannah, United States
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Seniority
Other
Department
Other
Location
Savannah
Industry
Biotechnology Research
Company size
725
Contact information
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c•••••••@blueprintmedicines.com
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Background
About Craig Chastain
Craig Chastain Savannah, GA 31412 writer1899@gmail.com 360-280-0587 Systems and Software – Office 365 | Veeva (Vault QMS, QualityDocs, Training, TMF, RIM)| ZenQMS | Qualio | Mac | Ubuntu | Visio | AdobeSign | DocuSign | Endpoint, Steeprock, 4G Clinical (RTSM/IRT systems | SAS | JMP | Smartsheet | AWS | Azure | Argus | Medidata (Rave, CTMS)| Egnyte | TrackWise | Tracelink | QUMAS | MasterControl | Gatekeeper | SAP | MS Dynamics GP | Selenium | JIRA | Bugzilla | Kneat | Blackboard | Moodle | Plateau | TrainCaster | ComplianceWire | ChatGPT | Copilot Technical Skills – Computer Systems/Software Validation and Assurance (CSV/CSA)| Software QA | Automated Validation Management (Selenium)| Technical Writing | GxP Technology Compliance | System Administration—Veeva, ZenQMS, Adobe Sign, Docusign | Validation Documentation (IQ, OQ, PQ, UAT, Summary Reports, User Requirements Specifications (URS), Functional Requirements Specification (FRS), Design Specifications)| Regulations (21 CFR Part 11, GDPR, DSCSA, EudraLex Annex 11, SOX, PIC/S)| Standards (GAMP5, ISO 9001, 27001, SOCII)| Quality Risk Management | Digital Signature Programs | Change Controls | Risk Assessments | CAPA Management | Quality Management Systems (QMS)| SaaS Configuration | AWS | Azure| External and Internal Software Audits | Vendor Risk Management—GxP Software | SDLC (Waterfall, Agile) People Skills – Very Strong Written and Oral Communication | Technical Jargon Translation | Professional Leadership | Stakeholder Management | Problem Solving | Adaptability | Project Management—Manage Multiple Projects | Cross-Functional Teamwork and Collaboration
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