Afia Asif Email & Phone Number

Denmark

Copenhagen, Capital Region Of Denmark, Denmark

Professional experience in Post Market Surveillance using technical complaint case handling, complaint data trending, outsourcing of technical complaint handling, and consequently generating CAPA for both marketed and clinical drug-device combination products.My main responsibilities for marketed and clinical medical device products include:-Chairman for Medical Device Complaint Surveillance Groups (CSG), Framework for investigating and approving technical faults.-Providing input to Quality Management Review based on PMS data.-Trending on technical complaint data to provide meaningful outcome for Management, Development, Production, Manufacturing, and Clinical Trial suborganizations in Novo Nordisk.-Escalating Product Quality insights by providing continuous feedback to stakeholders in all relevant parts of the organization and facilitating/generating CAPA.-Other experience: GMP, GCP, Drug-Device Combination products, Single Dose Devises, HGH devices, BRD products, Facilitator, Usability Engineering, User communication.

Copenhagen, Capital Region Of Denmark, Denmark

Extensive experience in Quality Assurance & Regulatory Compliance for Medical Device Development Projects mainly related to Novo Nordisk's Obesity Therapeutic Products including Durg-Device Combination Products, Single Dose Device (SDD) Products using Design Controls, FDA 21 CFR 820 & part-4, EU MDR 2017/745.My main responsibilities include:-Setting Quality direction for Medical Device Development Projects supporting with regulatory compliance based on design control, EU MDR, and ISO 13485, 14971, 11608, 62366.-Lead Project QA tasks: Leading and setting product quality & patient safety for Single Dose Device products, and SDD Configuration Management in collaboration with internal and external stakeholders including external suppliers.-Technical tasks: quality review of requirements engineering, design verification & validation, design control, cross-functional deliverables, and technical submission file/documents.-Operational tasks: setting direction for device project planning & risk identification and management, stakeholder management, providing guidance for project verification & validation, and supplier assessment and management, and supporting inspections and audits.-Other responsibilities: Supporting Audits & Inspection, Process owner for User Communication, Process owner for Usability Engineering, Driving QMS improvements, Leading DDS strategy to action goals, Training of new colleagues in QMS.

Copenhagen, Capital Region, Denmark

My main responsibilities included:-Technical tasks include: Development of RnD solutions for the core-technology, Idea & Concept Development, Mechanical Design and Documentation, Research on Material search, Research on Nano-engineered Scaffolding, Production methods, Product optimization and implementation.-Operational tasks: Requirement engineering, System engineering, Market & User analysis, Product optimization and implementation, Supporting development of Marketing Material, Disseminating technological capabilities and solutions to potential Customers.-Other experiences: Application Engineering, Developing solutions for user needs, Electro-mechanical sensing solutions development.

Copenhagen Area, Capital Region, Denmark

Developed micro/nano- structures were used as platform to program and guide differentiation of human neural stem cells into dopaminergic neurons which were characterized using various biological techniques such as confocal microscopy, SEM, qPCR, western blot etc.My main responsibilities include:- Development of in-vitro class-III medical devices for neuro-degenerative diseases- Development of electrochemical sensors for measuring in-vitro neuro-transmitters release- Device characterization testing & validation- Culture & Differentiation of Human Neural Stem Cells- Characterization of developed medical devices with Stem cells using Microbiology techniques such as PCR & Western Blotting- PhD project planning, execution, & dissemination activities in collaboration within Marie Curie framework around the Europe

Madrid Area, Spain

Copenhagen Area, Capital Region, Denmark

During my work as Nano-fabrication engineer, I developed various types of periodic and random micro and nanostructures and scaffolds in several materials such as polymers, silicon, and carbon. Some of which are micro/nano-pillars, micro/nano-grass structures, micro/nano- suspended structures, etc.Other experiences include:Microfabrication - Nanofabrication - UV lithography - Maskless UV lithography - Silicon wafer processing - multiple layer processing - Mask designing - isotopic etching - anisotropic etching - Thin-film deposition - Lift-off - Passivation layer processing - Binding - Dicing