Position- Validation Lead/Technical Author Duration-2 years
Location- Indianapolis, IN Job Description- Mandatory Functional Skills Over 10 years’ experience in Computer System validation, technical documentation, and knowledge management. · In depth understanding of regulatory requirements within the pharmaceutical industry related to Computer systems (21 CFR Part 11) · Keen eye for identification of Risks associated with IT solutions and able to make recommendations to manage them · Held IT validation roles in the areas of manufacturing, clinical development, regulatory and patient safety with Pharmaceutical companies · Significant experience in CSV through the entire Computer System lifecycle – from new solutions development, through maintenance (Releases, Change Management, CAPAs) to system retirement and data retention/disposition as applicable · Skilled at planning, managing and implementing projects with sensitivity to quality, timelines, and IT departmental constraints Desirable Functional Skills Computer Systems Validation (CSV) | Risk Assessment and Management | IT Policy and Regulatory Compliance | Gap Analysis and Remediation | Documentation and Records Management | Software Development Life Cycle (SDLC) | Technical Writing | Editing | Test Script Creation | Content Generation | Knowledge Management | End User Needs Analysis | Life Sciences Project Management and Facilitation | Quality Assurance | Training and Mentoring | Customer Service | Web Self-Help | Mandatory Technical Skills 21 CFR, Computer System Validation Desirable Technical Skills Expereince in Pharma GxP environment -- You received this message because you are subscribed to the Google Groups "Citrix and Sap problems" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To post to this group, send email to [email protected]. Visit this group at http://groups.google.com/group/citrix-and-sap-problems. For more options, visit https://groups.google.com/d/optout.
