Regulatory compliance
I worked in quality management for eight years. Quality assurance (QA) is crucial to regulatory compliance and chemistry, manufacturing, and controls (CMC) because QA departments ensure that all company activities align with regulatory standards and support the development of safe, effective, and high-quality products.
From working in quality management, I have expertise in documentation practices, data integrity, and audit preparedness, all essential in maintaining the rigour of CMC processes. My involvement in change control, deviation management, and risk assessment directly supported the consistency and reproducibility of manufacturing processes.
Additionally, I helped maintain validated systems critical for process development, scale-up, and commercial production. By working with product development teams, I ensured that scientific innovations were backed by compliance and quality, ultimately contributing to successful regulatory submissions and product marketing.
Writing
I have been a biotech industry writer, consultant, and contractor since 2018, and I regularly draw on my prior experience in these roles. My work in the pharmaceutical and medical device sectors includes diagnostics and focuses on human and animal health. My experience transfers to agriculture-related sectors including food production and environmental health.
My work in Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and ISO contributes to my knowledge of compliance and company operations. ICH is important to human health, and VICH is important to animal health. One Health addresses health threats at the animal-human-environment interface.
Formal life science education
My strong life science education includes a PhD in molecular microbiology where I used genetic, proteomic, and microbiological techniques daily, an MSc in pharmaceutical manufacturing technology which satisfies the EU Qualified Person (QP) education requirement, a BSc (Hons) in animal biology that considered animal-human-environment interactions, and an HND in horse (industry) studies from an agricultural college.
A QP releases pharmaceutical industry drugs. QPs nod that a product is okay for human or animal administration. A registered QP has a lot of company responsibility. All company department operations feed into getting a drug to market to make a profit and continue their operations. A QP assesses the product's quality and identifies whether any operations or departments were not performing their roles correctly. A drug that fails to meet regulatory requirements could harm patient health and, consequently, the company's reputation. In part for these reasons, a QP will not release substandard medicines.
