Overview
Work History
Education
Skills
Professional Overview
References
Timeline
Generic

Ellie Sattari

Castle Hill,Australia

Overview

16
16
years of professional experience

Work History

Auditor

DNV gl
09.2021 - Current
  • Auditing Quality Management System of companies to provide them with an Iso certificate.

Regulatory Affairs & Quality Assurance specialist

Vitabiotics Ltd
05.2012 - 07.2021
  • Responsibilities: Develop timelines and regulatory strategies for new products
  • Obtaining and maintaining government approval for nutritional and medicinal products and related materials
  • Collecting, compiling and preparing the materials needed for registration and submission to Ministry of health , Food and Drug Administration
  • Evaluating applicable laws and regulations to determine impact on company activities
  • Provide regulatory support and recommendations for the assessment of new products or existing products
  • Identifying and interpreting relevant regulatory Guidelines
  • Responsible for preparing, maintaining and reviewing standard operating procedures for regulatory associated activities and processes
  • Assessing approval and release of product related labeling and marketing materials (leaflets, brochures)
  • Ensuring continuous improvement within regulatory processes
  • Assess and prove compliance of CTD dossier, formulation, specifications, etc… with respect to regulatory requirements
  • Maintain and support communications with Health Authorities, stabilized relationships with key regulatory authority personnel
  • Reporting results and project updates to senior management
  • Making sure that the quality and Regulatory standards are clearly set up and communicated within the company
  • Assessments of change request and development of implementation plan
  • Responsible for preparing, maintaining and reviewing quality management system including training and internal audit, verifying all API and ingredients supplier in accordance with local GMP and PICs and ISO 9001:2015
  • Inspecting all contract manufacturing (pharmaceutical industries) based on Quality requirements
  • Verify and approve for raw materials and finished products release approval
  • Review and analyze technical data in batch record and all pharmaceutical relevant data and all deviations for releasing nutritional and medicinal product
  • Accountable for Quality and Regulatory system compliance
  • Making sure that products are manufactured according to legal and GMP requirements
  • Liaising with process teams to implement procedure improvement.

Responsible Pharmacist

Daya Darou
10.2009 - 02.2012
  • Responsibilities: Preparation the SOP (Standard Operation Procedure) for better distribution of medicine
  • Controlling on GDP (Good Distribution Practice) Controlling on GSP (Good Storage Practice) Manager of providing medicine from Iranian manufacturer and importing company
  • Manager of distribution medicine among all branches
  • Controlling on Recall products
  • Cooperate with all manufacturer and Importer company to make sure about the quality and safety of all products
  • Controlling and inspecting the pharmaceutical store in all branches
  • Educating employees to do their work complied with the SOP.

Regulatory Affairs Specialist

Aryan Sana
10.2009 - 02.2012
  • Responsibilities: Regulatory of all documents for importing supplement products
  • Preparation and regulating documents for registration of new products in Iran MOH.

Regulatory Affairs Specialist

Ministry of health/Food and Drug administration
09.2007 - 09.2009
  • Responsibilities: Regulatory of all documents for importing supplement products
  • Review and analyzing the Dossier of different products from foreign and local companies according to the Ministry of Health standards
  • Review products label, package, COA, stability studies, batch records and production/test method
  • Renewal of imported and local products license
  • Evaluating the SMF (Site Master File) of pharmaceutical plans
  • GMP inspection
  • Issuing permit for importing and manufacturing product

Education

Doctorate of Pharmacy (Pharm.D) -

Azad University, Tehran, Iran
01.2007

Skills

  • Regulatory affairs (Pharma and Dietary supplement),Quality Management System, project management, Pharmaceutical Quality Assurance, contract manufacturing- Quality agreements - medicinal products quality, Natural, traditional& supplemental products quality , GMP, PICS, ICH requirements Change management , Risk management

Professional Overview

Organized, attentive Regulatory & Quality Assurance specialist with more than 10 years of experience in nutritional and medicinal companies and pharmaceutical industries, developing standards, procedures and solutions to regulatory and quality challenges. PMP certified, in depth knowledge of project management, quality management system such as ISO 9001, and GMP, eager learner, motivated and result-oriented. Experienced in stakeholder management and managing cross functional projects and teams.

References

TBA upon request

Timeline

Auditor

DNV gl
09.2021 - Current

Regulatory Affairs & Quality Assurance specialist

Vitabiotics Ltd
05.2012 - 07.2021

Responsible Pharmacist

Daya Darou
10.2009 - 02.2012

Regulatory Affairs Specialist

Aryan Sana
10.2009 - 02.2012

Regulatory Affairs Specialist

Ministry of health/Food and Drug administration
09.2007 - 09.2009

Doctorate of Pharmacy (Pharm.D) -

Azad University, Tehran, Iran

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