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29

March

Quality Assurance

Pettit Pharma & Device Search - Sydney, NSW

Manufacturing & Industrial
Source: uWorkin

JOB DESCRIPTION

  • Do you have QA & RA experience in pharma and/or medical devices?
  • Do you have experience with the TGA and ISO9001?
  • Outstanding leader, great mentor to guide you

THE COMPANY YOU WOULD BE JOINING

  • For over 80 years this organisation has been supplying public and private hospitals, day surgeries, general practice, aged care facilities and specialist clinics with the best products from around the world.
  • As a single source supply business with distribution coverage across ANZ they are well positioned to service their customers with all their health and medical product requirements throughout Australasia.
  • They continuously explore and evaluate new solutions by collaborating with global manufacturers, who are innovative, to meet their customers’ needs.

WHAT YOU WILL LEAD, GROW & BE A PART OF

  • This Regulatory Affairs/Quality Assurance Specialist role will be responsible to contribute to the implementation and operation of the quality management system to ensure that the company meets its objective of providing timely, high quality and efficient service in compliance with internal policies, TGA regulatory framework and ISO 9001 standards as well as the requirements of State and Federal Legislation and other relevant regulations, codes and standards, including improvement plans.
  • The primary purpose of this role is to ensure that the service provided consistently meets both external and internal requirements in compliance with industry quality standards, current regulatory standards and contractual customer requirements.
  • You will be responsible for the Quality Management System in compliance with regulatory quality standards and guidelines and for the oversight, reporting and monitoring of the company's quality systems, including investigations, corrective/preventive actions (CAPA), training programs.
  • You will assist all departments in the generation of quality system documentation; such as, SOPs, work instructions / deviation / investigation reports, equipment/system qualification protocols and reports, and change controls etc.
  • You will be responsible for the inclusion of medical devices with the TGA and the monitoring and reporting of medical devices that the company maintains.

WHAT YOU WILL NEED TO GET THE JOB

  • You are self-motivated, reliable, have a high attention to detail, with a strong focus on integrity and professionalism.
  • Good understanding of Quality Management / ISO Certification Standards, GWP, TGA regulations and legislation.
  • Lead auditor qualifications or equivalent in management systems auditing and leading auditing teams.
  • Workplace Training and Assessment qualifications or equivalent preferred.
  • Knowledge of drugs, poisons and controlled substances regulations preferred.
  • Minimum 2 years’ experience in pharmaceutical manufacturing or related production environment and previous experience in pharmaceutical or medical device logistics or manufacturing environment in QA.
  • Experience in document control is essential.
  • Excellent English interpersonal and communication skills, both written and oral.
  • Ability to identify and resolve quality related issues.
  • Skills in MS Excel, Word, Visio and other MS applications preferred.

Interested? Please apply now or call Scott Della-Pietra on 02.8310.9266 quoting reference number 3108. Please note, your details/resume will not be sent anywhere without a formal interview and, if successful, your subsequent prior permission. Personal information provided will be used for recruitment purposes only and be treated in the strictest confidence. Only shortlisted candidates will be contacted.
3108