- 14 years of experience in Life Sciences with CSV Validation for GxP systems
- Serve as a subject matter expert for Quality Engineering practice on IT systems and solutions including
- Clinical Trial Management Systems CTMS Veeva CTMS Medidata Rave Oracle Siebel
- Regulatory Platforms Veeva Vault RIM Veeva Vault
- Laboratory Information Management Systems LIMS LabVantage LabWare STAR LIMS
- Supply Chain Kinaxis
- Knowledge of key Pharma regulations including 21 CFR Part 11 EU Annex 11 CSA 21 CFR Part 820 GAMP5 principles
- Know how of compliance with FDA EMA ICH and other regulatory frameworks for Life Sciences
- Participate in business development activities including proposals solution demos and client workshops
- Must have experience using Test management tools like ALM qTest JiRA
- Solid hands on experience in CSV CSA deliverables lifecycle including
- a
- Validation Plan
- b
- URS FRS analysis
- c
- Risk assessment
- d
- Val IQ OQ PQ test cases creation updates execution
- Familiarity with Valgenesis or Kneat is nice to have
- Familiarity with cloud technologies AWS Azure data standards GDPR HL7 and cybersecurity in regulated environments
- Strong communication interpersonal skills
- Ability to work independently and with cross functional teams is preferred