Validation Reviewer I

6 months ago

Bengaluru Karnataka, India Fortrea Full time

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Serves as a member of the project team with primary responsibilities for all testing and documentation, requirements to support global EDC solutions tasks.  Create and Execute validation test scripts as requested and document the test results.  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

Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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