Trisha Mehan

I have experience in Pharmacy, Clinical Trials, Manufacturing and Pharmaceutical Quality. I currently work at Guy's Hospital as a Senior Production Specialist, Non-Sterile Unit Lead.

As a Clinical-Technical Interface Pharmacist at GSTT's PMU my main responsibilities were to check and release Section 10 and non-sterile products manufactured under MS line. After approximately 1 year, I became the Senior Production Specialist (non-sterile). In order to uphold the quality within our department, I work closely with the operational team and liaising with the Quality team to solve any queries. I identify risks/ incidents and completed occurrences, deviations and CAPAs for them. I review the environmental monitoring data and update documents such as BMRs. As part of the remediation works, I was involved in the balance equipment IOPQs (drafting the documents and completing them with the operators in the cleanroom) and completing gap analysis/risk assessments for computerised systems, as support to the current Band 8 Pharmacists with Data Integrity work stream. Recently, I have been supporting the Clinical Trials team in setting up new trials; quoting, completing QRAs and sourcing labelling materials. I designed the feasibility and quoting template for the CT team. To set up new products to the unit, I write, review and approve process performance qualifications.

Previously, I was a Clinical Trials Pharmacist at MAC Clinical Research where I helped lead a team in pharmacy set up for numerous Late and Early Phase Trials, specialising in First Dose in Man, for leading industrial giants. My main role was managing the aseptic unit at the Manchester site. I have been exposed to GMP production, including drafting GMP batch manufacturing records and Annex 13 labels. Since joining the company, I have mastered Pharmacy/ Production document creation. These includes drafting Pharmacy Manuals, accountability logs and SOPs. My other responsibilities also included reviewing IMPD (to establish API/IMP stability, supply chains, releasing processes and compatibility for primary packaging), environmental monitoring (micro) results , conducting Pharmacy training across all 7 MAC sites and training in preparing IMP using aseptic technique.

I worked very closely with our company’s QPs and GMP QA Manager where I assisted them with CTA reviews, CAPAs/RCA, GMP set up and product development meetings to ensure trials follows EU regulations (Orange Guide and Clinical Trials Directive). Moreover, I was an independent QA checker for manufactured products (part of the release process for IMP products). This responsibility enabled me to become more aware about the importance of PQS and its effect on patient safety. I lead and completed the qualification and validation for the new GMP compliant aseptic unit (cleanroom) being developed in our company. Furthermore, adapting our current PQS to cover aspects of the new facility and the activities within it and getting it ready for MHRA inspection.

I completed my Masters in Pharmacy at King's College London; graduating in 2017. I completed my Pre-Registration at Wythenshawe Hospital (Manchester NHS Trust). I completed my post-grad Diploma in Pharmaceutical Quality and Regulations at UCL, graduating with a Distinction.