Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.
Act as the subject matter expert leading and executing software and interface validation requirements within the laboratory. Review laboratory requirements and define procedures for instrument and data management / data integrity to ensure continued compliance with global data integrity, computerised system lifecycle processes and software verification and validation and protocols.
* Identify and document validation requirements for laboratory software systems (including instrument application software) and interfaces
* Development of a master validation plan for laboratory software systems and interfaces
* Execution of validation protocols generating reports including validation reports and risk assessments as required
* Alignment and development of local procedures including user requirements, functional specifications, validation plans and protocols
* Review and document laboratory requirements, define and implement procedures for instrument and data management / data integrity
* Interact with equipment vendors and IT partners to support the development and implementation of data integrity controls
BASIC QUALIFICATIONS | EDUCATION:
* BSc in science, engineering, manufacturing or a related field
* At least 3 years’ experience in software validation, preferably within a laboratory environment
* Knowledge of computerised software validation requirements and procedures for laboratory instrumentation e.g. LC-MS, Immunoassay platforms, software, hardware and instrument qualification
* Experience of development and implementation of a software validation structure
* Ability to travel between sites
Ability to work independently or as part of a multidisciplinary team
Demonstrate logical thinking and an ability to manage multiple activities / priorities
Demonstrable experience in validation of laboratory software
Strong verbal and written communication skills with the ability to influence others
An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
We provide reasonable adjustments to qualified individuals with disabilities. To request a reasonable adjustment, please speak to your recruiter