Back to jobsEnsures that Equipment & Software Qualification is carried out in compliance with Global & Site Policies, SOPs & WIs.
Ensures that best software validation practices are employed by all departments so that Equipment & Software systems which have an impact on product or process quality are developed, validated and documented in a manner which provides assurance that the system conforms to both established Regulatory, Quality System, and technical requirements.
Provides guidance to teams on Non-Device Software Lifecycle processes at BSC including Equipment with Software, Software Only Systems, Spreadsheet Validation, Data Reporting Software, Artificial Intelligence Applications etc).
Reviews and approves all deliverables associated with Equipment & Software Qualification Lifecycle to ensure Equipment & Software is qualified per it intended use (e.g. QP, PRA/EHA, EFS, EQP, SCS, EQR) including deliverables from other Software Qualification Lifecycles as applicable.
Ensures that all new Equipment & Software, and updates to existing Equipment & Software systems are qualified according to established BSC Change Control processes.
Ensures that all discrepancies and deviations encountered in Equipment & Software Qualification projects are adequately controlled, documented and addressed by the Project Team.
Provides guidance and collaborates when required with project teams on associated documentation for equipment and systems.
Provides software validation/compliance/part 11/ data integrity guidance in accordance with BSC policies and SOPs and industry and regulatory standards.
Provides training to employees across various functions on Equipment & Software validation to ensure improved competency.
Drives a culture of Right First Time to support patient and product safety while ensuring increased time efficiency and cost effectiveness for the business.
Participates in Validation project teams and assists in determining project schedules. Works with teams and other departments across the plant to ensure project adherence.
Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Possess technical competency to drive improvement in the Software Quality department processes through automation.
Supports department initiatives in driving Business Service Excellence and VIP initiatives
