Software Quality Engineering Contractors
- Jacksonville, Jacksonville, FL
QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.
Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions!
The Software Quality Engineers (SQE) will support the business in:
- Leading software validation activities/projects with specific focus to manufacturing systems.
- Creating, reviewing and approving software validation documentation.
- Supporting the global streamlining and standardization of SDLC & software validation policies, procedures and processes for computerized systems.
- Reviewing and approving internal and vendor software development and test documentation.
- Working with MAKE engineering to support CSV improvement initiatives.
- Facilitating Change Validation as part of the Change Control Board as the SQE representative.
- Prioritizing and planning all assigned projects for the QA Software Validation Department.
- Executing and documenting qualification protocols and reports, reviewing and approving software test cases/scripts and code reviews.
- Strong background and experience in the Computer System Validation procedures, strategy and document development (manufacturing support systems, lab systems, PLC automation).
- Understand and background of enterprise wide systems and validation in GMP environment.
- Process Excellence Experience and certification preferred.
- Must have excellent communication and writing skills in English.
EDUCATION / EXPERIENCE
- Bachelor’s degree in Science
- 3 to 5 years in pharmaceutical engineering, focusing on Computer System Validation.
- 5 to 10 years with pharmaceutical validation experience
All your information will be kept confidential according to EEO guidelines.