Description
SUMMARY OF PURPOSE/FUNCTION:The validation group is responsible for all aspects of validating the standard software platform including hotfixes, new releases, and customizations.
ESSENTIAL FUNCTIONS:
- Assist with writing, reviewing and executing customer FATs, SATs and IOQs for a highly customizable software package. Completed under the direction of the Validation Manager.
- Assist with writing validation tests for software customizations requested by customers. In general, this work is completed under an accelerated timeline.
- Help develop and maintain SOPs.
- Write validation summary reports.
- Interact closely with customers for FATs.
- Other Duties as assigned
ESSENTIAL SKILLS AND EXPERIENCE:
- Validation experience: hands-on experience with the development and execution of FATs, SATs and IQ/OQs.
- Strong knowledge of 21 CFR Part 11, GAMP, audit trails, security features, cGMP, GDP and regulatory requirements for automated systems.
- Self-motivated and capable of adhering to strict deadlines is a must.
- Highly effective verbal and written skills, including technical writing, are a must.
- Ability to adapt the validation model in a rapidly changing environment
- Flexibility to multi-task and develop innovative solutions
To find out more about Real please visit www.realstaffing.com