SAS QA Lead

Duties: Responsible for developing test protocols, scenarios and scripts to test business critical applications in Development. Applies software testing principles and test case design concepts to complete these deliverables in different project phases, e.g. for Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). The main focus is on testing database applications designed for the management of clinical trials in client/server and web-enabled environments. The tests will be performed on new systems as well as for system upgrades, infrastructure changes and integration points with other applications. Makes sure that applicable regulations, guidelines and internal procedures related to quality assurance (QA) and validation are followed and applied. Works with IT project teams, database administrators, validation and QA staff.
Skills: Formal technical training in software development life-cycle (SDLC) methodologies, software testing methodology, and familiarity with software testing tools are a must. Experience in testing the creation and content of SAS datasets is highly desired. A good understanding of the principles of software validation in regulated industries is a plus, including 21 CFR Part 11, PDA 18, related FDA guidelines and regulations, as well as ICH GCP guidelines. Good interpersonal and communication skills are highly desirable. Experience in the biotech or pharmaceutical industry is desired. Technical skills should include good knowledge of Oracle databases, SQL language, UNIX and expertise in Oracle-based client/server and/or web enabled applications
Education: Bachelor''''''''s degree in Computer Science or a related discipline, and a minimum of four years of commercial experience with testing of database systems and SAS outputs
REQUIREMENTS
Duties: Responsible for developing test protocols, scenarios and scripts to test business critical applications in Development. Applies software testing principles and test case design concepts to complete these deliverables in different project phases, e.g. for Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). The main focus is on testing database applications designed for the management of clinical trials in client/server and web-enabled environments. The tests will be performed on new systems as well as for system upgrades, infrastructure changes and integration points with other applications. Makes sure that applicable regulations, guidelines and internal procedures related to quality assurance (QA) and validation are followed and applied. Works with IT project teams, database administrators, validation and QA staff.
Skills: Formal technical training in software development life-cycle (SDLC) methodologies, software testing methodology, and familiarity with software testing tools are a must. Experience in testing the creation and content of SAS datasets is highly desired. A good understanding of the principles of software validation in regulated industries is a plus, including 21 CFR Part 11, PDA 18, related FDA guidelines and regulations, as well as ICH GCP guidelines. Good interpersonal and communication skills are highly desirable. Experience in the biotech or pharmaceutical industry is desired. Technical skills should include good knowledge of Oracle databases, SQL language, UNIX and expertise in Oracle-based client/server and/or web enabled applications
Education: Bachelor''''''''s degree in Computer Science or a related discipline, and a minimum of four years of commercial experience with testing of database systems and SAS outputs