Daniel Kirk

Background

About Daniel Kirk

I am a fast learning, dedicated, and hardworking engineer who is always willing to learn and push himself. With over 25 years manufacturing experience across Defence, FMCG (Baby Care / Products), Medical Device, and Pharmaceutical Aseptic Fill / Finish industries, I am well versed in developing strategy for manufacturing scale-up and capacity expansion activities with experience ranging from small volume manufacturing through to high volume FMCG Lean Manufacturing. Experience and exposure to various associated regulations: o EN 14350 (drinking equipment)/ Regulation (EU) 2018/213 (cups & bottles)/ Directive 93/11/EEC (teats and soothers)/ EU Food Contact Materials Framework Regulation. o ISO 13485 / 21 CFR Part 820 (cGMP). o 21 CFR pt11 / EU Annex 11 / ISPE GAMP 5 methodology. o ICHQ9 / ISO14971:2019. I have worked in Quality, Product Design & Development, Process Engineering, Project Management, NPI, and Industrialisation departments, and have a demonstrable track record for delivering projects; NPI, Capacity Expansion, Manufacturing Strategy, OEE Improvements, Process Improvement / Six Sigma, Environmental Management Certification (ISO14001), and Pharmaceutical Quality Management Systems. I am also a certified Lean Six Sigma Black Belt.