Software Quality Engineering Contractors

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.

TECHNICAL COMPETENCIES:

• 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.