Application Designer

Project Role :Application Designer



Project Role Description :Assist in defining requirements and designing applications to meet business process and application requirements.

Must have skills :Computer System Validation (CSV)


Good to have skills :NA
Minimum

5 year(s) of experience is required


Educational Qualification :15 years full time education

Key Responsibilitiesa:Lead small teams and perform project validation activities b:Represent the compliance / validation team in internal meetings and gather data for metrics to report to management c:Collaborate with and coach all teams to ensure client processes and validation goals are understood and followed/met d:FDA and other regulatory guidelines
Technical Experiencea:Knowledge of Pharma Regulatory Compliance and CSV b :Knowledge of End-to-End CSV in GxP environment with deep experience in validation life cycle and V-Model c:Good understanding of Pharma Regulatory requirements including CFR Part 11 and GAMP5 guidelines d:Experience in V-Model and Validation life cycle of regulated projects e:GxP Awareness including Good Documentation Practices f:Experience in supporting external audits
Professional AttributesA:Strong analytical, communication skills b :Leadership and problem solving Skills
Educational QualificationBE Completed


Qualifications

15 years full time education