Profile Details

Contact

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USD 150 /hr

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Hire Ben C.

Australia

USD 150 /hr

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

Profile Summary

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.

Subject Matter Expertise

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

Services

• Writing
• Research
• Product Development

Writing Clinical Trial Documentation, Technical Writing

Research Systematic Literature Review

Product Development Formulation

Work Experience

Quality & Regulatory Manager

Logikal Health Products

April 2018 - Present

Consultant (Casual)

Critical Compliance

April 2018 - Present

Quality Assurance Officer (Casual)

Slade Health

April 2018 - September 2018

Senior QA Compliance Officer

Delta Laboratories

July 2017 - April 2018

Quality & Safety Manager

Logikal Health Products

August 2010 - July 2017

Quality Assurance Officer (Casual)

MobiLIFE

October 2012 - April 2017

Education

Diploma in Quality Auditing

Forsythes Training

October 2015 - July 2018

Master of Public Health

University of Newcastle, Australia

July 2016 - December 2017

Master of Workplace Health & Safety

University of Newcastle, Australia

January 2014 - June 2016

Bachelor of Biotechnology

University of Newcastle, Australia

January 2008 - December 2010

Certifications

• Certification details not provided.