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.
Laboratory Validation Manager
Working across 3 sites as a key member of the laboratory team and in conjunction with the Laboratory Quality Manager to develop and maintain the validation master plan and for managing the annual validation program. Ensuring that validation activities are completed in line with the Quality Management System and ISO requirements.
* Develop and maintain the validation master plan and manage the annual validation program
* Work in conjunction with technical SMEs to develop an equipment validation framework across all laboratories, R&D and the warehouse as appropriate
* Document and execute the validation protocol for laboratory equipment including heating blocks, balances and temperature probes
* Develop a temperature mapping framework, to include applicable items in the laboratories and warehouse, including a risk assessment of activities where appropriate
* Document and execute the temperature mapping protocol and associated risk assessments
* Review and refine existing validation standard operating procedures to define requirements laboratory equipment validation including new equipment and existing equipment that has undergone maintenance and repair
* Ensure compliance of laboratory equipment is maintained following preventative maintenance and repair visits.
* Review, update and maintain the laboratory asset registers ensuring all equipment and relevant components e.g. PC, pumps, appropriately recorded
* In conjunction with technical SMEs develop User Requirement Specifications for new instrumentation and equipment
* Working with laboratory and procurement teams develop and implement a process to record URS evaluation as part of the Capex process
* Become proficient in laboratory method validation protocols and existing procedures, undertaking review of individual validation protocols as required prior to submission in to the Quality Management System
BASIC QUALIFICATIONS | EDUCATION:
* BSc in science or a related field
* At least 3-5 years’ experience working in a regulated environment e.g. ISO17025, ISO13485
* Detailed knowledge of validation approaches within laboratory and manufacturing environments coupled with solid experience in development of master validation plan
* Experience of managing small teams
* Ability to travel between sites
Ability to work independently or as part of a multidisciplinary team
Demonstrate analytical thinking and an ability to manage multiple activities / priorities
Demonstrate knowledge of ISO 17025 and ISO 13485 requirements in relation to validation activities
Strong verbal and written communication skills with the ability to influence others
Good attention to detail
Fluent in Microsoft office
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