JULIE

SEBASTIANI

Address Toronto, ON, Canada

Phone + 33 6 10 80 68 96

Email adu7bb@r.postjobfree.com

SUMMARY

Professional with over 7 years of Quality assurance experience in the pharmaceutical industry. Management of quality systems and processes. Problem solver and detail oriented. Have worked in Europe and in Canada. Good knowledge of EMA and Health Canada GMP requirements. Excellent interpersonal and communication skills. Results driven; skilled leader focused on achieving success.

EDUCATION

Bordeaux, France University of Pharmacy

2017 – 2018

Master 2: Quality management in the pharmaceutical industries Marseille, France University of Pharmacy

2012 – 2016

Doctor of pharmacy

LANGUAGE

• French: Fluent

• English: Fluent

•

EXPERIENCE

Associate Director, Pharmaceutical Affairs

LINEPHARMA INTERNATIONAL INC., Canada

JUL 2022 /Current position

Manage three (3) departments within the Canadian organization (Quality; Supply Chain and Vigilance).

Provide support to Global Surveillance Patient Safety Department and Third Party towards the management of Medical Information and Vigilance responsibilities (including Individual Case Safety Reporting for the Canadian Territory and Australia). Provide direction to Supply chain and logistics area to ensure sufficient inventory of drug product is available to prevent drug shortage situations.

Direct and manage quality control and assurance activities such that drug products are released in compliance to local GMP guidelines/regulations. Monitor, and improve the effectiveness of the local Quality System and ensure compliance to Good Manufacturing Practices.

Revise, review/ approve Quality, and Safety Agreements with new and current business partners. Ensure timely reporting of non-conformances/issues with quality, safety, and financial impact to executive management as required.

2

Strategize and collaborate with functional groups to ensure timely completion of objectives and milestones.

Ensure departments are adequately staffed and organized to support ongoing responsibilities of marketed products and the growth of the organization. Support, direct, and coach subordinate employees.

Plan, monitor and control budgetary expenditures within each responsible area. Host internal and external inspections/audits — i.e. regulatory authorities; corporate Manager Supply Chain and Quality Assurance

LINEPHARMA INTERNATIONAL INC., Canada

FEB 2020 – JUL 2022

Management of 2 coordinators (Quality Assurance coordinator/Supply Chain coordinator) Quality Assurance

Electronic Controlled Document System local coordinator (training, management of rights, document creation, main point of contact with corporate and local employee) Management of critical quality management systems (Change Control, Complaint and Deviation process; CAPA process).

Participate in the creation, review, approval of GMP documentation. Evaluation of Manufacturer Product Quality Reports. Summarize Canadian data to complete Annual Product Review Reports. Preparation of the Quality Distribution Agreement. Liaise with local Partners to address non-conformances (product complaints) within their respective territory.

Management of Company Drug establishment license.

Preparation of Audit Plan and assist lead auditor during audit. Supervise quality assurance activities with quality coordinator and external consultant. Supply Chain

Manage customer orders process.

Direct point of contact (customer, corporate and third parties) for Supply chain topics. Approve reconciliation of order forecasts.

Manage storage and transportation requirements with corporate and third party vendors. Monitor status and resolve delays with Canadian supply and other territories. Manage the Canadian Inventory in order to avoid shortage and obsolescence. Notification of shortage to Health Canada.

Manage forecasting and supply chain requirements.

Supervise supply chain coordinator in daily supply chain functions. Coordinator Supply Chain and Quality Assurance System LINEPHARMA INTERNATIONAL LTD., France

APR 2019 – FEB 2020

Quality Assurance:

Promotion of the quality approach internally and monitoring of its application Assist Qualified Person for all the Quality Routine activities (Deviation, CAPA, Change Control, Product Quality Complaints, Controlled document updates) Assist Qualified Person in the planning & realization of internal and external quality audits Supply Chain:

Operational management of supplier orders and customer orders (Europe, Latin America & North America)

3

Main point of contact with the manufacturers

Inventory tracking

Monitoring of sales and planning of needs for finished products, packaging items and active ingredients

Assist Management for the implementation of the serialization Night Pharmacist

RECIPHARM, France

APR 2018 – MAR 2019

Batch file reviews of sterile products

Management of 13 people (manufacturing, filling and packaging) Coordination of production activities during the night shift Quality decisions on production issues during the night shift Production Project Assistant Intern

THERMO FISHER SCIENTIFIC, France

OCT 2017 – MAR 2018

Point of contact between the project engineer and production team (packaging and manufacturing) Controlled document updates

Assist project engineer with the follow-up of equipment installation projects Quality Assurance Intern

SANOFI, France

SEP 2016 – SEP 2017

Preparation of annual products quality reports:

o Data extraction, formatting and analysis

o CAPA management support and review of the effectiveness of the previous CAPA Quality and Regulatory Intern

SOLVIREX, France

MAR 2016 – AUG 2016

Implementation of quality performance indicators

Customer satisfaction surveys

Creation and improvement of existing controlled documents (sops & forms) Ensure compliance with french gmps

Implementation of a new activity (mouth care sticks) Implementation of the environmental label

Update of product information dossier and technical files drafting Regulatory monitoring

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