- Serves as a member of the project team with primary responsibilities for all documentation, requirements to support global EDC solutions tasks.
- Supports validation activities as assigned and serves as a validation team member.
- Review to make oneself familiar with the Validation specifications.
- Writes and assembles validation documentation packages such as but not limited to, validation plan, testing results, traceability matrix, validation reports.
- Support virtual global validation team as needed to complete validation projects
- Maintains and utilizes knowledge of SOPs and validation procedures/standards in relation to system development cycle.
- Assist in creation of error tracking logs.
- Assist project teams with validation tasks as requested.
- Execute validation test scripts as requested.
- Ensure quality of work
- Prioritize workload to meet specified completion dates
- Assist with the maintenance of validation metrics.
- Carry out all activities according to Covance 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.
- Assist with special projects as designated.
- University/college degree (life science, computer science, programming, pharmacy or related subject preferred), or certification in a related profession from an appropriately accredited institution (e.g., nursing certification, computer science, medical or laboratory technology)
- 2 - 4 years of relevant work experience to include Validation support and execution.
- Good problem-solving skills and a proactive approach
- Good oral and written communication skills
- Good time management skills and maintain the highest standards of quality work
- 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 new technology and a constantly changing work environment.
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