Jaimin Patel, MSc Toxicology, B Pharmacy, ARPharmS, QP, RP, RPi, UKRT/ERT has Post graduated in Toxicology (Acute and Chronic Toxicity)from the University of East London, London, UK & he has completed Bachelor of Pharmacy (Pharmaceutics) from Rajiv Gandhi University of Health Science University, Karnataka, India.
He became Qualified Person (QP) under Qualified Person under Permanent Provision of 2001/83/EC.
He is Responsible Person (RP)under GDP requirements (2013C/ 343/01) following Cogent Approved Gold Standard Responsible Person course. He is active as QP & RP on the MIA and WDA licences issued by MHRA in the UK and MMA in Malta.
He is acting as Responsible Person Import (RPi) in UK from January 2021, main change following Brexit in the UK. He is active on WDA licence a RPi issued by MHRA in the UK.
He has completed Lead Auditor training in in GMP Pharmaceutical Quality system (GMP PQS) and holdsLead Auditor accreditation with IRCA. He has expertise in auditing active substance manufacturer / suppliers, Contract manufacturers, Quality control laboratories, Storage warehouses and excipient manufacturers.
He has also completed several certification courses such as Nitrosamine assessment and Evaluation, Computer system validation, Quality by design, Cross-contamination, Data integrity and Pharmaceutical dispensing NVQ level 2
He is a member of Royal Pharmaceutical society, British Toxicology society, Malta Pharmacy Council and IRCA.
He is approved as Toxicologist Expert in United Kingdom register of Toxicology (UKRT) and European Register of Toxicology (ERT).
He has experienced 15+ years in Pharmaceutical Industry mainly in EU GMDP i.e., Zydus Cadila & Henley India Pvt Ltd, B&S Group, Syri Limited & Wockhardt UK, Uni Health Distribution & Biovantic Pharma Ltd with Different areas like Pharmaceutical Product Development, Quality Assurance, Quality Control, Manufacturing and Regulatory affairs..
He successfully handledmany Regulatory Authorities audits, predominantly from MHRA for GMDP operations. He has extensive experience of implementation & Continual Improvement of Quality Management System for new / existingGMDP licence (EU GMP, EU GDP & ISO 9001), he also provides guidance on remedial plan for resolving Critical observation following Regulatory Authority audits.
He is a Certified Toxicologist who has extensive experience on dealing with Permitted daily exposure reports for Active substances (PDE Reports / HBEL Reports), Elemental impurity risk assessment, Nitrosamine risk assessment,Genotoxic impurity assessment,Toxicological safety determination of Unknown Impurity and Module 2: Non-clinical dossier review and approval.
He has conducted several internal & External audits on an International basis forAPI manufactures& Suppliers, CMOs, Brokers, Quality Control Laboratories& GDP warehouses.
Some of his key areas are Product Formulation development, Quality Risk Management, Quality by design (QbD), Technology transfer of Formulation, Scale up, Manufacturing process Transfer, Auditing, Process Validations, Computer system validation, Cleaning Validations, Facility & Equipment validation, Vendor Qualification, Supply chain management, Training, Outsourcing, GLP and QMS.
He has Good multi-tasking abilities with appropriate blend of Quality and Technical skills with Commercial awareness.
He defined the name KeyQP to provide Compliance Key via QP qualification and experience.
