Ash Puri
Area Manager United Kingdom @Accurate Global Inc
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WORK HISTORY
Area Manager United Kingdom @Accurate Global Inc
London, GB
I am responsible for expansion, audit planning, contract review, technical code assessment, on-site auditing, and certification of ISO 9001, ISO 14001, ISO 45001, ISO 13485, and ISO 27001 standards for organisations.
EDUCATION
Rajiv Gandhi University of Health Sciences
Bachelor's degree, Pharmacy
APJ school jalandhar
10th
IRCA
Auditor, GMP
SKILLS
ABOUT ASH PURI
Medical Device ISO 13485, MDD 93/42/EEC, MDR 2017/745• UK Responsible person (UKRP) Medical Device• Authorised Representative medical devices • Contract RP on WDA(H) Licence• Contract RP for Cosmetics manufacturer• Clinical Evaluation Plans (CEP) Clinical Evaluation Report (CER)• Regulatory Submissions (CE, MDR, 510k) • Technical File & Design History File Remediation (Class I, II, IVD, PPE and Cosmetics technical files and providing Gap Analysis)• ISO 13485 and ISO 9001 Implementation from scratch• Risk Management (ISO 14971)• Quality Management System, Total Quality Management; EFQM• Regulatory Affairs Management• Risk Management ISO 14971 –2012, ISO 14•••••19• Project Management • Regulation (EU) 2016/425 of 9 March 2016 on personal protective equipment• EN ISO 90••••15, ISO 14001 EQMS Implementation • The General Product Safety Regulations 2005• REGULATION (EC) No 1223/2009 on cosmetic products.• Biocide Product Registration.• Leadership Development • Quality Management System Integration and Global Quality System Harmonization• Technical Reviewer for Design History File (DHF) and Technical File• CE Mark submission UK(MHRA) and EU (EUDAMED). • Vigilance Report; Recall, FSN, FSCA, MIR; Post Market Surveillance (PMS)• Six Sigma, Process Control, Continuous Improvement (CI), Lean Manufacturing and Services, Control Plan, 5S• Internal & External Audits• FMEA, PFMEA, DFMEA, • Supplier Assessment, Supplier Selection, Supplier Survey, Supply Chain, Supplier Product Development• NPI, NPD, KPI, • CAPA, 8D, PPAP, 5 WHY’s, Fish Bone, SPC, RoHS/REACH, Validation (IQ, PQ, OQ), HHE• Temperature Mapping
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