Sr. CSV


Summary of Tasks:
Participate in Full CSV SDLC documentation support within a FDA regulated environment with an emphasis on enterprise-scale IT systems including but not limited to:
  1. Requirements elicitation and engineering
  2. Performing data integrity/data quality assessments
  3. Authoring and reviewing user requirements / functional requirements specifications, design specifications, computer validation plans, test protocols, data integrity assessments and part 11/annex 11 assessments.
  4. Tracking and maintaining document records and metrics in the SharePoint, DocCompliance and ValGenesis systems. 

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