Carly Hardy

Carly Hardy Email and Phone Number

Medical Device and Pharmaceutical Manufacturing
Carly Hardy's Location
Greater Perth Area, Australia
Carly Hardy's Contact Details

Carly Hardy phone numbers

About Carly Hardy

I thrive on challenges (2016 Graduate from the Founder Institute) and am a life-long learner! A self starter who can work independently but prefers collaborative endeavours. I manage competing priorities to solve manufacturing, design and development challenges in time and to all applicable regulatory requirements. I relish a technical problem, finding novel solutions when necessary.

Carly Hardy's Current Company Details

Medical Device and Pharmaceutical Manufacturing
Carly Hardy Work Experience Details
  • Reset Mind Sciences
    Head Of Quality
    Reset Mind Sciences Nov 2022 - Apr 2024
    Perth, Western Australia, Australia
    Currently validating a new GMP Facility in Perth, open to contracts. Feel free to contact me about your small batch needs.
  • Little Green Pharma
    Technical Services Manager
    Little Green Pharma Nov 2022 - Aug 2023
    Perth, Western Australia, Australia
    After settings up post harvest GMP activities for the Cannabis Flos Operations and seeing approx 80 crops come through as HoP, I’ve handed over routine production and joined the Quality Team working on New product introductions & process upgrades.
  • Little Green Pharma
    Head Of Production
    Little Green Pharma Feb 2021 - Nov 2022
    Western Australia, Australia
  • Orthocell Ltd
    Quality Projects Lead
    Orthocell Ltd Jul 2020 - Dec 2020
    Murdoch, Western Australia, Australia
  • Pharma/ Devices
    Operations Manager
    Pharma/ Devices Mar 2020 - Jul 2020
    Perth, Australia
  • Go Medical Industries Pty Ltd.
    Quality Assurance Regulatory Affairs Manager
    Go Medical Industries Pty Ltd. Apr 2019 - Mar 2020
    Perth, Western Australia, Australia
    Managed the manufacture, registrations and market approvals of 8 devices, manufactured across three countries and sold into Australia, Asia, Europe and America.
  • Sabre Medical
    New Product & Production Engineer
    Sabre Medical Jan 2016 - Mar 2020
    Australia /Asia, (Based In Perth, Sydney, Adelaide)
    I work with Sabre & client MDMs on various medical device projects. I have experience with developing washing/cleaning/packing/sterilisation (EO, gamma, steam) processes, protocols, SOPs, forms & validation reports. Preparing dossiers for CE marking & doing preparatory ISO 13485 audits. I have implemented a variety of ISO standards into practices (eg. ISO 14971, 14644, 14698) for a variety of orthopedic & biotech companies.
  • Kooda
    Founder & Ceo
    Kooda Sep 2016 - Jan 2020
    Perth, Australia
  • Kooda
    Founder
    Kooda Jun 2016 - Jan 2020
    What if none of our organic waste went to Landfill?
  • The Gate Presents
    Co-Founder
    The Gate Presents Apr 2010 - Feb 2019
    Sydney, Australia
    Original ideas. Strategy, Logistics, Invoices, submissions, insurance. Book keeping.
  • Sabre Medical/Engineering
    Quality Manager /Biomedical Engineer
    Sabre Medical/Engineering Aug 2013 - Dec 2017
    Lane Cove West
    As Quality Manager at Sabre Medical I have overseen the implementation of our ISO 13485 Quality System, the building and qualification of our class 7 cleanroom production suite and control and supply of sterile product for start-up medical device manufacturers. Next Steps: NATA accreditation of our established Package Testing Laboratory & continuing to support R& D projects in the medical device field with cleanroom services and sterile barrier system expertise. ISO 13485 Lead… Show more As Quality Manager at Sabre Medical I have overseen the implementation of our ISO 13485 Quality System, the building and qualification of our class 7 cleanroom production suite and control and supply of sterile product for start-up medical device manufacturers. Next Steps: NATA accreditation of our established Package Testing Laboratory & continuing to support R& D projects in the medical device field with cleanroom services and sterile barrier system expertise. ISO 13485 Lead Auditor (IRCA approved) Medical Device Barrier Systems and Package Validation. Package Testing Laboratory Services (Method Validation). Stability Studies.Passivation (of implants) Process Validation. Device Cleaning (residuals) Validation.Sterilization Validation (Ethylene Oxide or Radiation), Release of Sterile Product. Medical Device Consultant,- Compiling Part B Technical Design Dossiers. Supply Chain Auditing and Lean Manufacturing. Cold Chain Distribution packaging Development & Validation. Show less
  • St Vincents Hospital
    Biomedical Engineer
    St Vincents Hospital 2006 - 2008
    Sydney, Australia
    Responsible for the regular repair, testing and calibration of a variety of electrical medical equipment.- Performance, electrical safety testing as well as acceptance testing of equipment to AS/NZS 3551:2004 Technical management programs for medical devices- Communicating with staff members effectively to ensure work is distributed and addressed in the most efficient manner.- Responsible for proper record keeping of repairs with the use of hospital based Equipment Management System… Show more Responsible for the regular repair, testing and calibration of a variety of electrical medical equipment.- Performance, electrical safety testing as well as acceptance testing of equipment to AS/NZS 3551:2004 Technical management programs for medical devices- Communicating with staff members effectively to ensure work is distributed and addressed in the most efficient manner.- Responsible for proper record keeping of repairs with the use of hospital based Equipment Management System (EMS) - Performing electrical area testing of patient areas to AS/NZS 3003:2003 Electrical installations - Patient treatment areas of hospitals and medical, dental practices and dialyzing locations - Organising and performing preventative maintenance checks of vital equipment - Defibrillators, Ventilators and Electrosurgical Units - in the hospital. - Provide on site and on-call support to hospital staff enquiries regarding equipment use and troubleshooting Show less
  • New College Unsw
    College Chemistry Tutor
    New College Unsw Feb 2005 - Nov 2005
    Unsw
    Champion the Academic Life of the College, and uphold it's commitment to academic excellence.- Ran weekly Chemistry tutorials for 1st year Undergrads.- 1 hour of consultation time, to assist anyone with Chemistry problems related to any coursework.- Aid students in Exam preparation- Liase with other tutors, and together provide assistance, to students not achieving well.- Co-ordinate study groups for students enrolled in similar courses

Carly Hardy Skills

Technical Writing Multitasking Skills Mass And Energy Balance Calibration Research Projects Communication Process Engineering Design Of Experiments Iso 13485 Design For Manufacturing Medical Devices Biomedical Engineering Polymers Validation Research Project Management R&d Laboratory Quality System Matlab Test Method Validation Quality Systems Engineering Product Development Capa Microsoft Office Manufacturing Gmp Lean Manufacturing V&v Process Improvement Quality Assurance Research And Development Biotechnology

Carly Hardy Education Details

  • University Of New South Wales
    University Of New South Wales
    Chemical Engineering
  • Muru-D Plus 8
    Muru-D Plus 8
    Founding, Business Management, Leadership
  • University Of New South Wales
    University Of New South Wales
    Thesis: Mass Transfer Of Proteins In Uv Cross-Linked Pva
  • The Founder Institute
    The Founder Institute
    Graduated!

Frequently Asked Questions about Carly Hardy

What is Carly Hardy's role at the current company?

Carly Hardy's current role is Medical Device and Pharmaceutical Manufacturing.

What is Carly Hardy's direct phone number?

Carly Hardy's direct phone number is +614220*****

What schools did Carly Hardy attend?

Carly Hardy attended University Of New South Wales, Muru-D Plus 8, University Of New South Wales, The Founder Institute.

What are some of Carly Hardy's interests?

Carly Hardy has interest in Live Music, Jesus, In 10 Years, Early Childhood And Development, Social Enterprise, I'd Love To Start My Own.

What skills is Carly Hardy known for?

Carly Hardy has skills like Technical Writing, Multitasking Skills, Mass And Energy Balance, Calibration, Research Projects, Communication, Process Engineering, Design Of Experiments, Iso 13485, Design For Manufacturing, Medical Devices, Biomedical Engineering.

Not the Carly Hardy you were looking for?

Free Chrome Extension

Find emails, phones & company data instantly

Find verified emails from LinkedIn profiles
Get direct phone numbers & mobile contacts
Access company data & employee information
Works directly on LinkedIn - no copy/paste needed
Get Chrome Extension - Free

Aero Online

Your AI prospecting assistant

Download 750 million emails and 100 million phone numbers

Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.