Carly Hardy phone numbers
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.
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Head Of QualityReset Mind Sciences Nov 2022 - Apr 2024Perth, Western Australia, AustraliaCurrently validating a new GMP Facility in Perth, open to contracts. Feel free to contact me about your small batch needs. -
Technical Services ManagerLittle Green Pharma Nov 2022 - Aug 2023Perth, Western Australia, AustraliaAfter 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. -
Head Of ProductionLittle Green Pharma Feb 2021 - Nov 2022Western Australia, Australia -
Quality Projects LeadOrthocell Ltd Jul 2020 - Dec 2020Murdoch, Western Australia, Australia -
Operations ManagerPharma/ Devices Mar 2020 - Jul 2020Perth, Australia
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Quality Assurance Regulatory Affairs ManagerGo Medical Industries Pty Ltd. Apr 2019 - Mar 2020Perth, Western Australia, AustraliaManaged the manufacture, registrations and market approvals of 8 devices, manufactured across three countries and sold into Australia, Asia, Europe and America. -
New Product & Production EngineerSabre Medical Jan 2016 - Mar 2020Australia /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.
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Founder & CeoKooda Sep 2016 - Jan 2020Perth, Australia -
FounderKooda Jun 2016 - Jan 2020What if none of our organic waste went to Landfill?
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Co-FounderThe Gate Presents Apr 2010 - Feb 2019Sydney, AustraliaOriginal ideas. Strategy, Logistics, Invoices, submissions, insurance. Book keeping.
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Quality Manager /Biomedical EngineerSabre Medical/Engineering Aug 2013 - Dec 2017Lane Cove WestAs 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
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Biomedical EngineerSt Vincents Hospital 2006 - 2008Sydney, AustraliaResponsible 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
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College Chemistry TutorNew College Unsw Feb 2005 - Nov 2005UnswChampion 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
Carly Hardy Education Details
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University Of New South WalesChemical Engineering -
Muru-D Plus 8Founding, Business Management, Leadership -
University Of New South WalesThesis: Mass Transfer Of Proteins In Uv Cross-Linked Pva -
The Founder InstituteGraduated!
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.
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Carly Hardy
Wirral -
Carly Hardy
Greater Seattle Area1dillanos.com -
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