Associate Validator II
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Job Description
Documentation Validator supporting Global EDC Solutions by managing documentation and validation tasks. Collaborating with project teams to ensure quality and adherence to GCP guidelines.
Responsibilities:
- Serve as a member of the project team with primary responsibility for all documentation requirements in support of Global EDC Solutions tasks.
- Assist project teams with validation tasks as requested, i.e., with the creation, production, printing and tracking of study documentation and controlled documents.
- Create and execute validation test scripts as requested and document the test results.
- Ensure quality of work.
- Prioritize workload to meet specified completion dates.
- Assist with the maintenance of validation metrics.
- Carry out all activities according to Fortrea Standard Operation Procedures (SOPs) and project specific conventions within the framework of Quality Management and Good Clinical Practice (GCP)/ICH guidelines.
- Maintain accurate records of all work performed.
- Perform other duties as assigned by management.
Requirements:
- University / college degree (life sciences, health sciences, information technology or related subjects) or a certification in allied health professions from an appropriate accredited institution.
- Fluent in English, both written and verbal.
- 3 years of validation experience working with a global CRO/Pharma.
- A neat, methodical, and thorough approach to the work with an emphasis on attention to detail.
- Good concentration skills are required to meet the consistently high standards expected.
- Self-motivation with the ability to work under pressure to meet demanding deadlines.
- Effective communication skills and the ability to work as part of a team.
- Flexibility – being able to move from one computer system to another with ease and adapt to modern technology and a constantly changing work environment.
Benefits:
- Home based
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