Senior IT Validation Analyst - Remote / Telecommute
Senior IT Validation Analyst - Remote / Telecommute
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Job Description:
Responsibilities:
- Creation, review, approval, and DMS processing of Computer System Lifecycle deliverables for Projects and Change Controls:
- Validation Plans/Summary Reports.
- Risk Assessments.
- User Requirements.
- Specifications.
- Test Plans.
- Test Scripts: IQ, OQ, or PQ.
- Assess and implement the most effective validation stXXgy for each activity.
- Oversee test execution for cross-functional teams, including training, tracking, and reviews.
- Build strong relationships with business counterparts to understand processes and requirements, ensuring delivery of compliant computer system solutions.
- Work effectively with IT colleagues to ensure compliance with validation processes and proper documentation.
- CollaboXX with Information System Quality Assurance (ISQA) to ensure compliance on all projects, procedures and audits related to Information Technology.
Education and Experience Requirements:
- BS/Equivalent Training/Certification and a minimum of 5 years of relevant experience in computer systems validation, change management, and systems development life cycle methodologies.
Necessary Knowledge, Skills, and Abilities:
- Expertise in Computer System Validation (CSV), Systems Development Life Cycle (SDLC) methodologies, and CSV regulations, standards, and best practices.
- Working knowledge of Computer Software Assurance (CSA) guidance and its applicability.
- Excellent written and verbal communication skills with a focus on Good Documentation Practices (GDP).
- Technical knowledge of the following computer systems and software (at a minimum):
- MS software packages such as Outlook, Word, Excel, PowerPoint, and MS Project
- SAP, LIMS, or other Candidateufacturing, Distribution, and Laboratory systems
- Veeva Vault.
- ServiceNow.
- Robust knowledge and understanding of pharmaceutical manufacturing, packaging, operations, quality, and supply chain processes and related systems.
- Working knowledge of project management principles, and ability to opeXX under tight timelines, within budget, and to specified quality and compliance goals.
- Solid relationship and conflict management skills, and ability to navigate complex, fast-moving business environments in a self-directed manner.
Seniority level
Seniority level
Mid-Senior level
Employment type
Job function
Job function
Information TechnologyIndustries
Software Development
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