Device & Packaging Engineer, DipPkgTech, MIMMM, with extensive experience in the Pharmaceutical Industry (FMCG) due to managing a multitude of complex projects, specialising in various areas such as Change Control (CFR21.211), Technical Drawings (CAD) and Specifications, Supplier Changes, Complaints (ISO 9000/9001), Serialisation, Artwork (Adobe CC&AEM), FAT, SAT, IQ&OQ, Development, PQ&PV, Transit Qualification (ISTA/ASTM D4169), Stability Coordination, Device Functionality, Technical Transfers and NPIs. Effective in managing cross functional teams with a risk based approach using industry standard software.Throughout my career, I have successfully designed, managed and commercialised Primary, Secondary and Tertiary Packaging Components e.g. Manual and Auto Injector Medical Devices (Injectables and Inhalations), Bottles, Vials, Tubes, Stoppers (Pharmacopeia), Overseals, Blisters, Sachets (E&L), Trays, Cartons (FEFCO), Leaflets, Labels (CFR21.801/EudraLex Annex 13), Tamper Evidents (DSCSA), Cases and more. My expertise covers the entire spectrum of Pharmaceutical Packaging Design and Commercialisation.I have also gained significant experience in Combination Product Development (Drug/Device), including Design Verification (ISO 11608) and Validation (ISO 13485), Design History File (DHF)/Technical File (EUMDR) management (CFR21.820/ICH Q8), Risk Management (ICH Q9/ISO 14971/15223) and Design Control (ISO 13485) in line with Quality and Regulatory requirements (ISO 11607/CGMP/ICH/EudraLex).In addition to my packaging expertise, I have successfully supported and managed the implementation of various types of equipment (ISO 14644/OSHA) including High Speed Device Assembly and Primary, Secondary and Tertiary Packaging Equipment including Serialisation (UDI) and Aggregation (all key markets). My knowledge and experience also extends to areas such as SAP/MM (M-ERP), Non-printed/printed component PLM and product localisation as an SME with significant system migration experience.I have a very strong understanding of all supporting functions, the processes and systems used and their interdependencies. Additionally, I am qualified in multiple different disciplines; Mechanical Engineering, Packaging, Print, Graphic Design, Design, Adobe CC, CAD, etc.I am highly motivated, proactive and reliable. I have demonstrated leadership abilities through effectively managing technical/cross functional teams. I am keenly curious and love to learn how things work. Turns out my superpower is digesting complex topics and making them simpler for everyone to understand.