Jaimin Patel
Quality Consultant (Contract Qp, Rp, Rpi, Principal Toxicologist & Lead Auditor) @Keyqp Quality Services Limited
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WORK HISTORY
Quality Consultant (Contract Qp, Rp, Rpi, Principal Toxicologist & Lead Auditor) @Keyqp Quality Services Limited
Slough, GB
To act as Contract QP, RP or RPi on MIA /WDA licence and fulfil the respective duties To write, implement and improve the Pharmaceutical Quality Management of the clients in paper based or electronic format To conduct the audit of the site as Contract Lead Auditor in API Manufacturer, GDP suppliers, GLP labs, CMOs To provide assessment, project plan & full service for a client to get new EU GMDP certificates and licences as MIA, WDA, MS, API WDA or Veterinary use To provide consultancy services for initial assessment of site compliance and provide resolutions for identified gaps in areas as validation, quality management system, outsourcing, risk management, vendor assurance program, Excipient risk assessment, data integrity & governance, computerised system, and their controls To provide Permitted daily exposure reports (PDE) Approved by Certified Toxicologist expert To prepare, assess and approve reports on Nitrosamine, Elemental impurity, Genotoxic impurities as Toxicologist To provide on-site training on areas as GAMP CSV, QMS, GMP, GDP, Data Integrity & data Governance, Excipient risk assessment, FMEA risk management, process validation, stability study, new product development QBD, and FMD To conduct review of Clinical, Non-clinical and Quality dossier and provider approved summary to use in Dossier To provide API QP Declaration To set up Technology transfer from Development lab to commercial manufacturing, analytical method transfer & process validation
EDUCATION
University of East London
master of toxicology, Toxicology
Reading Scientific Services Ltd
Responsibe Person (GDP Gold Standard RP), GDP
University of East London
Masters, Toxicology
Inspired Pharma
lead auditor pharmaceutical QMS, Auditing
ECA Academy
Master Class - Computer system validation, CVS - GAMP5,Annex 11, CFR21 Part 11
Rajiv Gandhi University of Health Sciences
Bachelor's degree, Pharmacy
Reading Scientific Services Limited
QP modules, Quality
SKILLS
ABOUT JAIMIN PATEL
A Principal Toxicologist, Qualified Person (QP), Responsible Person (RP) and Responsible person for Import (RPi), 15+ years of cumulative experience in Pharmaceutical industries mainly EU GMDP with expertise in areas as below,Batch CertificationPrepare SOPs & PoliciesAct as Contract QP, RP or RPICMO ManagementPharmaceutical Quality Management system implementation (GMP & GDP) Setting up an MIA & WDASetting up Controlled drug Home Office licenceResolving Critical observations from Authority auditsQuality Risk assessment Vendor Approval & ManagementPlanned Change management Deviation & Complaint management OOS OOT ManagementExternal & Internal Audits Computer System Validation Technical AgreementNew Product/Formulation development Technology transfer, Scale up & Process Validation Excipient risk assessment Data Integrity & Data Governance Training and CoachingFacility & Equipment validation Process Validation Cleaning validationPermitted daily exposure reports (PDE Report) Supply chain management SerializationNitrosamine impurity assessment Recall Temperature MappingRoot cause Analysis Transport validation Outsourcing managementGenotoxic impurity assessment Elemental impurity assessment Product Quality ReviewRPi process implementation and checks
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