プロフィール詳細

プロジェクトを作成

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Ben C.に依頼

Australia

Therapeutic Goods Consultant: Quality Systems, Regulatory Affairs, Auditing, Product Development and Validations

プロフィール概要

I'm a therapeutic goods industry professional, working within the Australian medical device and pharmaceutical manufacturing sectors since 2010. I specialise in all things Quality and Regulatory, with experience working at all risk levels, from Class I non-sterile and non-measuring devices through to terminally sterilised product and aseptically compounded medicines. I have numerous contacts, both academic and professional, across a range of organisations. Therefore, if I cannot help, then generally I know someone who can! I have completed undergraduate studies in Biotechnology, and post graduate studies in the fields of both Workplace Health & Safety and Public Health. In addition to my university qualifications, I also hold a Diploma in Quality Auditing, HACCP accreditation and number of other certificates/accreditations.

専門分野

• ★ Pharmaceutical Sciences
• ★ Medical Devices
• ★ Quality Assurance & Quality Control (QA/QC)
• ☆ European Medical Device Regulation (MDR)
• ☆ Pharmaceutical Management
• ☆ Pharmaceutical Technology
• ☆ Product Compliance

サービス

• Writing
• Research
• Product Development

Writing Clinical Trial Documentation, Technical Writing

Research Systematic Literature Review

Product Development Formulation

職務経験

Quality & Regulatory Manager

Logikal Health Products

4月 2018 - 現在

Consultant (Casual)

Critical Compliance

4月 2018 - 現在

Quality Assurance Officer (Casual)

Slade Health

4月 2018 - 9月 2018

Senior QA Compliance Officer

Delta Laboratories

7月 2017 - 4月 2018

Quality & Safety Manager

Logikal Health Products

8月 2010 - 7月 2017

Quality Assurance Officer (Casual)

MobiLIFE

10月 2012 - 4月 2017

学歴

Diploma in Quality Auditing

Forsythes Training

10月 2015 - 7月 2018

Master of Public Health

University of Newcastle, Australia

7月 2016 - 12月 2017

Master of Workplace Health & Safety

University of Newcastle, Australia

1月 2014 - 6月 2016

Bachelor of Biotechnology

University of Newcastle, Australia

1月 2008 - 12月 2010

認定資格

• 認定資格の詳細は未入力です。