Quality Systems Officer

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ANSTO are seeking a Systems Officer with experience in GMP, ISO & ARPANSA to manage & coordinate a portfolio of quality system elements

Summary about this job

Quality Assurance & Control

Company: Australian Nuclear Science and Technology Organisation

Location: Sydney

Work type: Full Time

Salary: n\a

Phone: +61-8-5969-2879

Fax: +61-3-3718-7029

E-mail: n\a

Site:

Detail information about job Quality Systems Officer. Terms and conditions vacancy



About ANSTO

The Australian Nuclear Science and Technology Organisation (ANSTO) is home to Australia’s nuclear science and technical expertise. More than 1000 scientists, engineers and experts work at ANSTO and use nuclear science and technology to answer the big questions in the world around us – improving health outcomes, increasing our understanding of the environment and climate change and identifying new opportunities for Australian industry.

We operate much of our country’s landmark science facilities including one of the world’s most modern nuclear research reactors (OPAL). Importantly, ANSTO is helping to improve our health with one in two Australians benefitting from the nuclear medicines produced using the OPAL research reactor while being treated for serious illnesses such as heart disease and cancer.


About the Position

The Quality Systems Officer will be responsible for maintaining key parts of the quality system including continuous improvement, audit, change control and document management in compliance with the requirements of TGA license to manufacture therapeutic goods,  the PIC/S Code of GMP for Medicinal Products, ISO 9001, TGA, FDA, ARPANSA regulatory requirements and the ANM Quality Management System.

To be successful in this role, you will have experience working in a highly regulated environment, be proactive in identifying and rectifying quality system issues in a timely manner and continuously look for improvements to processes and systems.  Reporting to the Quality Assurance Leader, you will co-ordinate quality management systems, customer complaints, provide reports to management and be the main source of expert advice and support.


Duties and Responsibilities

  • Manage and coordinate a portfolio of quality-system elements within the ANM Quality Management System
  • Lead, identify and propose improvements to the Quality Management System and implement changes
  • Continuously improve quality system processes including preparing relevant quality-system documentation to ensure compliance with regulations and QMS requirements
  • Perform the role of authorised person for release for use or supply of materials used and produced in ANM and authorise release of API
     

Skills and Experience

  • Tertiary qualification in Chemistry or an equivalent qualification with experience in pharmaceuticals industry
  • Experience in working in a highly regulated environment including GMP, ISO9001 and ARPANSA
  • Demonstrated ability to interpret the cGMP and apply to specific situations, especially PIC/S Guide to Manufacture of Medicinal Products Part II
  • Demonstrated ability to develop and maintain quality systems to GMP and ISO9001 standards

“Looking for a self-starter who has exceptional organisational skills and has worked in a highly regulated GMP environment in the quality assurance area.”
Margaret Sequeira & Quality Assurance Leader


Why join ANSTO?

ANSTO employees are passionate about what they do. We enjoy being part of an organisation making a difference in the lives of Australians.

We support and reward our employees through eligibility for:

  • Training, development and mentoring opportunities
  • Performance based salary increases
  • Work-life balance with generous leave entitlements and flexible conditions
Located in the Sutherland Shire, we have free onsite parking, a swimming pool, health and wellbeing programs and an onsite café.

If you want to join a world class organisation that’s making a difference in the lives of Australians, apply now!

 
 TO APPLY and view the Position Information Package please visit www.ansto.gov.au and follow the links to the Current Vacancies page.

For further technical information relating to this position please refer to the Position Information Package or contact Margaret Sequeira on (02) 9717 9195  or  Michael Gobrial on (02) 9717 9430 .  For all other queries please contact the HR Shared Services Team on +61 (02) 9717 3111.

To be eligible for appointment, applicants will require a security and pre-employment medical assessment.

All applicants must be Australian citizens.

Applications must be submitted on-line via our website.

In order to solve great challenges, we need great minds and great teams. At ANSTO, we understand that diverse teams produce better outcomes – and we value the merit that a diverse perspective can bring to our team. We encourage people from diverse backgrounds to apply for our roles including Aboriginal and Torres Strait Islander people, primary carers, those with a disability, and women in STEM. ANSTO is a charter member of the Science in Australia Gender Equity (SAGE) initiative and is proudly taking action to create a gender-inclusive workforce.

ANSTO is an Equal Opportunity Employer

Applications close: 31st July 2018

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