Emile Arrey. MSc. D.E.S.S.

Experience

• 

  FLANDERS INTERUNIVERSITY INSTITUTE OF BIOTECHNOLOGY (VIB)

  Sept 2006 - Sept 2007

  Master Degree in Biomedical and Pharmaceutical Science Internship

  -Writing up of Pharmaceutical and technical investigation reports; collection and appropriate documentation of data for monthly presentations at the departmental meetings, seminars and thesis board meetings. -Rotations in the different departments (Regulatory affairs, Pharmacovigilance, Clinical research, Medical and technical writing ) to obtained profound knowledge on various scientific references like the Pharmacopoeias (USP); European union (EU) legislation in the pharmaceutical sector-Eudralex; ICH guidelines; GMP and the regulations that apply to Bioequivalence studies for Biologics products (Biosimilars). Show less

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  INSTITUTE OF MOLECULAR BIOLOGY AND BIOTECHNOLOGY

  Sept 2007 - Oct 2008

  Pharmaceutical Research Associate

  -Participate in writing, preparation, compilation, review and submission of Pharmaceutical Research papers, Pharmaceutical Brochures and documentations use in Research workshops and seminars organized by the Company. -Attended departmental meetings to adopt and prepare new SOPs as per the GLP, GMP and regulatory guidelines; to ensure and improve the quality, safety and purity of the Biologics product produce. -Attended the yearly GMP and GLP courses, seminars and examinations conducted by the QA department as per the new GMP and GLP practices followed by the Company. -Trained the junior staff of the department on the Eudra GMP guidelines and regulations that applies to Biologics, as well as the pharmacists students who came for their internship at the Company. Show less

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  Pharmascience

  Sept 2015 - now

  • Leads Site Compliance Inspection Readiness activities and continuous projects improvement (based on trends, internal audit observations, etc.) that can be leveraged across departments, functions, and Product families. • New Product Introduction: acts as Compliance Representative in new Product introduction activities and document approval.• Supports New Product launches and business initiatives. Participates in continuous improvement in Projects.• Leads the Qualification and Certification Program for Suppliers; and the Periodic Performance Review (PPR) of Suppliers based the established SOP.• Coordinate GMP Audit Inspections activities for Foreign Building Supplier’s adherence to GMP compliancy.• Participate in Activities related to Health Canada or Us FDA GMP Audit Inspections, Foreign Site GMP Non-compliant Inquires, Product recalls, Health Canada's Products inquires and Quality Risk Assessments. • Performing GMP Compliance due diligence for both Domestic and Foreign Sites for Product launches and Business initiatives.• Management, Administration, Maintenance and Annual License Review of Pharmascience Inc. and her affiliated Establishment Licenses (Drugs, Medical Devices and Natural Health product) according to Business evolution.• Quality Assurance Agreements Negotiations, Management and Maintenance. Show less • Participate in Activities related to GMP Audit Inspections, Foreign Site GMP Non-compliant Inquires, Product recalls, Health Canada's Products inquires and Quality Risk Assessments.• Management, Administration, Maintenance and Annual License Review of Pharmascience Inc. and her affiliated Establishment Licenses (Drugs, Medical Devices and Natural Health product) according to Business evolution.• Negotiates and Maintains Quality Assurance Agreements with Partners in accordance with business need.• Supports Product launches and business initiatives. Participates in continuous improvement projects.• Subject Matter Expert (SME) in Compliance related Change Controls Initiation, Evaluation and Review. Show less • Participate in Activities related to Regulatory Authorities /Clients GMP Audit Inspections.• Participate in Activities related to Product recalls, Health Canada's Products inquires and Quality risk assessments. • Write-proof, Review, Management and Maintenance of Quality Assurance Agreements (QAA) between Pharmascience Inc. with her Partners for Business needs (Launching of New Products and change requests).• Management, Administration, Maintenance and Annual License Renewal of Pharmascience Inc. and her affiliated Establishment Licenses (Drugs, Medical Devices and Natural Health product) according to Business evolution.• Expertise in the Evaluation and Review of Conformity and Compliance related Change Controls. Show less • Coordinate activities associated to the Product Live Cycle such as; Evaluate / Analyze Post Approval Change Controls and provide Regulatory evaluation based on Regulations, Guidelines and Policies; Prepare and submit Level III and IV Change Control Notification.• Prepare and keep up-to-date CMC Regulatory Documents (CPID, QOS etc.) for various Product (OTC and Rx Drugs) in target Countries (Canada, USA and Europe) including Change Controls History from approved to current CPID.• Ensures Post-Market Regulatory Compliance: Evaluate / Analyze all proposed Post-Approval product changes through Change Controls, and provide regulatory expertise and / or classification based on current Regulations, Guidelines and Policies; also send applicable Notifications to Regulatory Authorities within the mandatory delay after implementation date of the Change Control. • Update, Maintenance and Management of the CPID database of the company. Provide Regulatory Expertise to other departments for requests generated by the AskReg service. Show less

  • Senior Corporate Compliance Specialist

    Nov 2021 - now

  • Corporate Compliance Specialist

    Jun 2019 - Nov 2021

  • International Compliance Coordinator

    May 2017 - Aug 2020

  • Regulatory Affairs Associate Post CMC

    Sept 2015 - May 2017