Conducts user testing and validation for systems developed by the department. Performs document management functions including, but not limited to, document review, organization and archiving. Performs routine auditing functions to ensure that the department is operating in compliance with PPD and Federal regulations.
- Performs IRT system validation including writing and/or executing test scripts and/or performs review of documentation supporting IRT system testing.
- Completes required testing documentation.
- Completes thorough review of reports or related documentation.
- Performs archival procedures for systems as required by SOPs.
- Conducts internal audits to ensure the quality of services for the department.
- Performs special project validations such as software upgrades (e.g., Oracle 7.3.3 to 8I).
- Provides training to junior team members.
Education and Experience:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
- Good understanding of writing validation plans, test cases and validation summary reports
- Good understanding of software development and software quality control processes and systems
- Strong planning, organization and project management skills, including the ability to adjust to rapidly
- changing priorities
- Working knowledge of regulatory guidelines and requirements, including FDA 21 CFR part 11 regulations
- Strong oral and written communication skills
- Good understanding of the MS Office application suite
- Strong attention to detail
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Able to work upright and stationary for typical working hours.
- Ability to use and learn standard office equipment and technology with proficiency.
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
- May require travel. (Recruiter will provide more details.)