Declan Broderick Email & Phone Number

Sweden

Uppsala, Sweden

• Independently execute all activities related to a clinical evaluation, including (but not limited to):
• Clinical site selection
• Site contract and budget negotiation
• Study initiation visits
• Data monitoring activities, including on-site and remote audits of study data for accuracy, integrity, and completeness
• Protocol development in line with ISO 20916 (2019)

Parkmore Galway

• Provided Design Assurance input to support the development and verification of innovative (class III) implantable devices that resulted in US and EU approvals
• Developed device inputs, design specifications and sample sizes for verification and validation programmes based on a risk based approach
• Prepared design verification and validation plans, protocols, and reports as part of the cross-functional team
• Managed test verification and validation protocol execution - scheduling of internal and external testing, deviation resolution, and data review
• Performed data analysis including normality assessments, data transformations, generation of descriptive statistics, and trending of quality data
• Managed the calibration and preventative maintenance systems

Galway

• Performed verification and validation testing in a cGLP environment
• Developed verification and validation test methods for new products including Labcoat
• Revised current test methods to incorporate latest regulatory and standard requirements
• Optimised lab efficiency as part of continuous improvement programme in the Design Assurance lab
• Performed all lab calibration and preventative maintenance activities. Maintaining calibration log of all lab equipment
• Managed training schedule and tracking matrix

• Co-ordinated 5S project on the start-up of a new lab
• Updated standard operating procedures to ensure compliance with Siemens Medical policies and procedures for new transfer kits
• Provided training to current (cross-training) and new employees
• Performed analysis using Enzyme-Linked Immuno Sorbent Assay’s (ELISA) together with QCS software
• Complete monthly maintenance of the Immulite machines

• Commissioning & Validation: (2003-2005)
• Supervised automation engineers during Factory Acceptance Testing for 3 months in Emerson in Leister (UK) and reported progress to Wyeth (Dublin)
• Conducted PID walk downs of buffer and media equipment
• Executed functional equipment module, phase and unit testing on plant
• Reported deviations from expected results and performed effective troubleshooting
• Executed validation protocols on all buffer and media equipment including IQ (Instrumentation Qualification), PQ (Production Qualification) and OQ (Operation Qualification)