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I have:
- Prepared a variety of industry documents that meet regulatory requirements. This has contributed to my continuous learning of regulations which are always being improved by regional regulators.
- Worked on quality management for products distributed to and stored at clinical trial sites. This strengthened my understanding of how regulations apply to clinical trial and marketed products manufacturing and distribution.
- Graduated from an industry-accepted Qualified Person course. This bolstered my understanding of where regulations and manufacturing operations meet.
- Worked as a clinical trial auditor, so I reviewed Essential Documents listed in ICH GCP. GCP auditing allowed my regulatory understanding to flourish.
- Written medical device industry clinical evaluation reports and developed the clinical evaluation procedures for a medical device company.
If you are looking for someone who is down to earth, approachable, engaging, communicative, inspiring, analytical, problem-solving, creative, detail oriented, organised, adaptable, motivated, and driven look no further because I am those things. I like journeys towards innovation and success.
Things that resonate with me include pharmaceutical and medical device production and distribution, agriculture, animal health, antimicrobial resistance, biotechnology, combination products, compliance, countryside management, crop spoilage, the environment and environmental health, food production, gene pools, GMO, grassland management, human health, life science, One Health, regulations, quality management, and zoonoses.
Let me know how I can support your goals and help drive your projects forward.