Jas Patel Email & Phone Number

United Kingdom

Responsible Pharmacist duties, including final professional, legal and clinical checks on dispensed prescriptions; counselling patients on the use of medicines; training and management of pharmacy teams; provision of medicine-use review, new-medicine review, supervised-methadone consumption and flu-vaccination services; safeguarding children and vulnerable adults; signposting patients; and taking part in health-promotion schemes.

Canary Wharf, United Kingdom

Use of technical-chemistry, manufacture and controls expertise to assess the acceptability of National, EU (DCP and MRP) and variation (Type IA, IB and II) applications; writing reports and RFI letters to applicants to communicate deficiency points; and liaising with other European competent authorities, as appropriate, to ensure the progress of applications within legislative time-frames.Ensuring the applicant’s compliance with relevant directives, ICH, EMA and MHRA guidelines with a focus on Module 1 (including product names, SmPCs, PILs, product-labelling artwork and mock-ups), Module 3 and Module 5 assessment of the Common Technical Document.- Assessment of initial ASMFs and ASMF updates for active substances.- Assessment of applications concerning oral dosage formulations (tablets, modified-release tablets, capsules, sublingual and buccal tablets, solutions and suspensions); transdermal patches; and injectables (IV-, SC- and IM-administered formulations). - Critically assessing dosage form design and dissolution data in relation to biowaiver requirements for generic applications, submitted under Article 10(1), 10(3), 10a of Directive 2001/83/EC.- Assessing the acceptability of primary packaging and dose-delivery devices.Writing papers and delivering presentations regarding applications deemed to pose potential serious risk to public health, for scientific committee meetings held by the Commission on Human Medicines and Expert Advisory Groups concerning the protection of public health.Providing ad-hoc regulatory advice to applicants, concerning on-going applications.Provision of scientific and regulatory advice for companies at scientific-advice meetings.Ensuring accurate product life-cycle maintenance.Working in collaboration with colleagues in other MHRA divisions such as inspection, enforcements and standards division to make critical decisions concerning ongoing procedures.

Analysis and investigation of active pharmaceutical ingredients, intermediates and process samples to support project work; method development, troubleshooting and aiding in method validation processes; and development of experimental reports.Supporting the establishment of Pharmaron’s Good Manufacturing Practice (GMP) analytical chemistry laboratory. Ensuring the GMP qualification of analytical systems including: - analytical balances, water activity meter, auto-pipettes, refrigerators, freezers, thermometers, ovens and photostability cabinets in accordance with USP, NIST, ISO and ICH standards and guidance- general maintenance of laboratory instruments post-GMP qualification and inventory. Writing standard operating procedures for use and maintenance of laboratory equipment.GMP validation of stability chambers in preparation for ICH stability studies; development of validation documents including protocols and reports, URS, IOQ and validation reports, and critical mapping exercises for the installation of temperature and humidity monitoring probes.Working with Quality Assurance teams on deviations; change controls; OOS and CAPAs; and implementing workflows for sample management.

Master’S Degree, Pharmaceutical Analysis & Quality Control, Distinction

Activities and Societies: Pharmaceutical Analysis and Quality ControlAwarded the "Lingard Prize for Best Overall Student in PAQC 2016".

Master’S Degree, Pharmacy

Lab skills and techniques; - ELISA analysis, optimising drug formulations, molecular modelling and kinetic analysis using various.