Carly Hardy Email & Phone Number

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.

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.

Western Australia, Australia

Murdoch, Western Australia, Australia

Perth, Australia

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.

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.

Perth, Australia

What if none of our organic waste went to Landfill?

Sydney, Australia

Original ideas. Strategy, Logistics, Invoices, submissions, insurance. Book keeping.

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

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

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

Bachelor Of Engineering (Beng), Chemical Engineering

Founding, Business Management, Leadership

Masters Biomedical Engineering, Thesis: Mass Transfer Of Proteins In Uv Cross-Linked Pva

Entrepreneur Program, Graduated!

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