CSV Consultant
- Category: Et cetera
- Deadline: 01st May 20232023-05-01T01:00:00-0700
- California
Position: CSV ConsultantLocation: San Diego, CA area or in one of the pharma/biotech hot spots: Greater San Francisco, Chicago, Boston, New Jersey, Philadelphia, or North CarolinaDuration: 6-12+ MonthsDescription:
Apply This Job
- Lead validation workstream by capturing business processes and requirements, authoring key computer systems validation deliverables and liaising with client and vendor personnel to drive deliverables to completion.
- Work with other client team members and vendor personnel to implement solutions, inlead and participate in testing to ensure implemented solutions meet requirements, and author key operational documents such as Standard Operating Procedures, Work Instructions, and training materials.
- Engage client personnel, support project managers to develop clear plans, prepare for workshops, create effective PowerPoint decks, facilitate sessions, coordinate with vendor personnel, create compelling communication materials, and support implementation efforts to achieve client objectives.
- Possess a degree from an accredited, four-year college or university; advanced degrees and certificates/certifications are highly desirable (e.g. PMI-PBA, Six Sigma, CAPM, PMP)
- Have at least 5 years of relevant work experience as a business analyst or project-based consultant working on business transformation and/or IT implementation projects; experience in biotech/pharmaceuticals and experience with GxP computer systems validation is required.
- Strong technical writing experience writing standard operating procedures
- Experience in authoring documents such as risk assessments, validation plans, user requirements, traceability matrices, testing documentation and test summary reports, knowledge base articles, etc.
- Knowledge of 21 CFR Part 11, EU Annex 11, GDPR, SOC 2
- Experience implementing and continuously improving regulated and non-regulated SaaS, PaaS and IaaS-based systems.
- Ability to develop and execute technology-based strategic plans, policies, and standard operating procedures.
- Experience with quality management and computer systems validation
- Ability to handle changing and competing priorities where the path forward is not always clear at the outset and accurately identify problems, determine options to address problems, identify pros and cons of potential options, and recommend a solution.
- Strong communication skills to clearly communicate with remote stakeholders to sufficiently inform on your progress with initiatives or deliverables.
- Mastery skill using Microsoft Word, Excel, PowerPoint, and Visio and familiarity with Microsoft Office 365, Microsoft Project, SharePoint, OneNote, and Teams
- May live anywhere within the United States but strong preference will be given to those located in the San Diego, CA area or in one of the pharma/biotech hot spots: Greater San Francisco, Chicago, Boston, New Jersey, Philadelphia, or North Carolina
- Eligibility to work in United States
Similar jobs
Robert Half - Project Manager/Sr. Consultant
San Diego County Office of Education - Functional Consultant, Human Capital Management Application and Systems Development (SDCOE)