The Authorised Person / Qualified Person will be responsible for ensuring that all medicinal products manufactured and/or imported by TriOn Pharma comply with their Marketing Authorisation, meet all applicable regulatory requirements, and are manufactured in accordance with Good Manufacturing Practice (GMP). The role will involve certifying each batch prior to release for sale or supply, maintaining quality standards, and ensuring continuous compliance with MHRA and EU GMP guidelines.
Key responsibilities will include:
Batch certification and release in accordance with UK and EU GMP requirements.
Oversight of manufacturing, importation, and quality control processes to ensure compliance with the company’s Manufacturer’s/Importer’s Authorisation (MIA).
Reviewing and approving manufacturing documentation, deviations, change controls, and CAPAs.
Ensuring compliance with relevant sections of the Human Medicines Regulations 2012.
Liaising with the MHRA, suppliers, and contract manufacturers on quality matters.
Supporting internal and external GMP inspections.
Leading investigations into quality incidents and implementing corrective actions.
Providing guidance and training to other quality personnel within TriOn Pharma.
Skills, Experience, and Qualifications Required:
Eligibility to be named as a Qualified Person (QP) under Directive 2001/83/EC and the UK Human Medicines Regulations 2012.
Honours degree in Pharmacy, Chemistry, Biology, or another relevant discipline.
Successful completion of the QP training programme as recognised by the Joint Professional Bodies (Royal Pharmaceutical Society, Royal Society of Biology, Royal Society of Chemistry).
In-depth knowledge of UK and EU GMP regulations and pharmaceutical quality systems.
Minimum 2 years’ experience in a GMP-compliant manufacturing or importation environment.
Strong attention to detail, problem-solving skills, and the ability to make sound, compliant decisions under pressure.