Quality Systems

2 months ago


Lucas Heights, Australia ANSTO Full time

**Position Overview**:

- Ongoing| Full Time | $129- $144k +15.4% super
- Work-life balance | Free onsite Parking | Health & Wellbeing Programs | Sporting Facilities
- On-site Childcare for employees | Work in a campus-based community environment | Cafe on site
- Looking for someone with experience with management of quality systems & end-to-end GMP manufacturing experience?

**About the Opportunity**:
The Quality Systems & Compliance Manager manages the quality system functions of Nuclear Medicine to ensure compliance with the requirements of the TGA licence to manufacture therapeutic goods, Nuclear Medicine Product Quality System (PQS) and other regulatory requirements. This includes:

- Developing and maintaining the licensed state to manufacture both finished goods and APIs through oversight of the Pharmaceutical Quality System (PQS) with established standards and agency guidelines to ensure compliance.
- Ensuring a constant state of compliance and audit readiness is maintained in line with current regulations, Quality Standards, and business needs.
- Manage quality systems inclusive of management of change (MOC), corrective actions and preventative actions (CAPA), audits, document management, deviations, supplier management, out of specification-tolerance(OOS-OOT), Product Quality Review (PQR), customer complaints, and sterility assurance.
- Management of validation schedule ensuring compliance for process, equipment, and computer systems
- Management of Sterility assurance ensuring regulatory compliance

**About You**:
**Your Duties and Responsibilities**:

- Managing all quality systems for Nuclear Medicine
- Monitor and report on all quality metrics and trends
- Manage qualification and validations to ensure all compliance expectations are met
- Subject matter expert for sterility assurance and determine continuous improvement initiatives
- Lead education programs for compliance requirements across relevant facilities
- Oversee transition to revised PIC/s Code to GMP Annex 1

**About Us**:
**Benefits of Working with Us**:
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

**How to Apply**:
For further technical information relating to this position please refer to the Position Description or contact Lee-Ann Carrasco on (+61) 476 246 149. For all other queries please contact Talent Acquisition on +61 (02) 9717 9361.

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

**Application closing date: 04 November 2024 at 11:59pm**

**_Australian citizens preferred_



  • Lucas Heights, Australia ANSTO Full time

    **Position Overview**: - 2 x Ongoing Positions Available | Full Time | $93k - $105k +15.4% super - Lucas Heights I Generous leave provisions I Free onsite car park - Great opportunity to maintain high standards and drive excellence in Quality Management Systems **About the Opportunity**: The Quality Business Management (QMS) Analyst is responsible for...


  • Lucas Heights, Australia ANSTO Full time

    **Position Overview**: - Ongoing | Full Time | $80k - $105k +15.4% super - Lucas Heights I Generous leave provisions I Free onsite car park - Great opportunity to provide safety engineering risk analysis **About the Opportunity**: **Your Duties and Responsibilities**: - Contribute to safety and engineering risk analysis of facilities, plant, equipment,...

  • Quality Manager

    3 months ago


    Allambie Heights, Australia Sunnyfield Full time

    TG Quality Manager Are you a hands-on, collaborative Quality leader who develops strong stakeholder relationships and thrives on developing and maintaining the highest quality standards? The Sunnyfield Employment Services division offers TG commercial packaging and assembly solutions for local, national, and international brands whilst creating employment...

  • Relief Motel Manager

    2 weeks ago


    Lucas Heights, Australia Cater Care Australia Cater Care Services Full time

    **Introduction**: Real opportunities to grow and develop - Attractive rosters - meaning more quality time with family and friends - Competitive Remuneration **Description**: **Role**: - - The Relief Motel Manager is responsible for ensuring the smooth and efficient operation of the motel during the absence of the primary manager. This position involves...

  • Service Desk Officer

    6 months ago


    Lucas Heights, Australia Collaborate Recruitment Pty Ltd Full time

    **Permanent role |Based in Sutherland Shire|AU Citizen ONLY**: - **Experience in 1**st** Level support and ITIL |On Site role |NO On Call**: - **Onsite Parking|** **Sporting facilities including swimming pool**, Gym** Our client is looking for Service Desk Officer to provide efficient and effective resolutions as the first level of any IT operational...


  • Lucas, Australia Ballarat Family Dental Full time

    **Are you up for a challenge?** **Are you looking for an organised team environment to be a part of where solid systems are in place and everyone is clear on who they report to and what's expected of their roles?** Ballarat Family Dental is a fun, modern practice looking for an experienced dental assistant who is committed to the profession, and loves...


  • Eastern Heights, Queensland, Australia Allstar Recruitment Group Full time

    Job SummaryWe are seeking an experienced Engineering Service Manager to join our client, a leading provider of Control Systems, Instrumentation & Automation systems to major Oil & Gas / LNG projects. This is an exciting opportunity for a talented professional to lead the delivery of Control / Automation solutions in the Resources industry.About the RoleThe...


  • Lucas, Australia Ballarat Family Dental Full time

    **Dental assisting experienced/traineeship for personal growth & career progression in a fun, supportive environment. Strong work ethics & humility a must!** - **You are honest, dependable and organised, seeking a stable career change**: - **4 day work week to clock full time hours. Saturdays on monthly rotation only**: - **Structured 6 wk training program...

  • Nurse Coordinator

    3 months ago


    Lucas, Australia Ballarat Community Health Full time

    The primary site for this position is: Lucas Close date: Mon, 7 Oct 2024 11:59pm **Nurse Coordinator - Pathways to Good Health** Join BCH as Nurse Coordinator for the Pathways to Good Health! Lead a passionate team to transform health for children in care. Make a difference! **About us**: Ballarat Community Health is a for-purpose, not-for-profit...


  • Eastern Heights, Queensland, Australia Allstar Recruitment Group Full time

    Job DescriptionThe Allstar Recruitment Group is seeking a highly skilled Automation Systems Engineering Manager to join their team in Perth.About the RoleTo manage and coordinate the delivery of control systems, instrumentation, and automation solutions to major oil and gas/LNG projects worldwide.Collaborate with cross-functional teams to ensure timely and...

  • Dental Assistant

    2 months ago


    Lucas, Australia Ballarat Family Dental Full time

    Ballarat Family Dental is excited to announce that we are looking for a self-starting dental assistant to join our growing team! Our practice recognises the importance of supporting our new team members so that they can integrate into our practice confidently and comfortably. **When you join our team as an experienced, qualified dental assistant, you will...


  • Allambie Heights, New South Wales, Australia Cerebral Palsy Alliance Full time

    About the RoleThe Digital Learning Specialist - Training Excellence works within the CPA Training Team to provide high-quality online learning opportunities.This role consults, reviews, updates, develops and implements contemporary and engaging online learning.Key ResponsibilitiesCollaborate with subject matter experts across the organisation to develop...


  • Allambie Heights, New South Wales, Australia Sunnyfield Full time

    Sunnyfield, a leading not-for-profit organisation in NSW, is seeking an experienced Mechanical Production Technician to join its team in Allambie Heights. As a key member of the Sunnyfield Packaging Services team, you will play a vital role in ensuring the efficient and safe operation of machinery in a TGA environment.With a focus on delivering high-quality...

  • Centre Administrator

    7 months ago


    Seaford Heights, Australia Green Leaves Early Learning Centres Full time

    **Description**: At Green Leaves Early Learning, we take pride in building innovative and sustainable learning environments in our state-of-the-art, purpose-built centres. Our Seaford Heights Centre is looking for a Centre Administrator to oversee enrolments and manage compliance within the service. Our centre offers early education and care to children...


  • Allambie Heights, New South Wales, Australia Sunnyfield Full time

    Sunnyfield Packaging Services, a leading provider of commercial packaging and assembly solutions in NSW, is seeking an experienced Assembly Operations Specialist to join their team.The ideal candidate will have strong mechanical aptitude, technical qualifications, and at least 2 years of relevant experience. They should be able to work effectively in a...


  • Allambie Heights, New South Wales, Australia Sunnyfield Full time

    Sunnyfield, a renowned not-for-profit organisation in NSW, is seeking an experienced Assembly Line Machinist to join their Sunnyfield Packaging Services team. The ideal candidate will be responsible for setting up and maintaining machinery in a TGA environment, ensuring production operations meet customer requirements and deadlines.About the Role:Setting and...

  • Assembler

    7 months ago


    Chelsea Heights, Australia LivaNova Full time

    Join us today and make a difference in people's lives! PRODUCTION OPERATOR Purpose & Context At LivaNova we unite to provide hope for patients and their families through innovative medical technologies, delivering life-changing improvements for the Head and Heart. As a part of the LivaNova Family you commit to uphold our Mission, Value and Pillars to; -...


  • Allambie Heights, Australia Sunnyfield Full time

    Sunnyfield is a large not-for-profit organisation with a Person Centred approach to providing services to people with disability. Part of Sunnyfield is Sunnyfield Enterprises, which offers commercial packaging and assembly solutions for local businesses across NSW. Sunnyfield Enterprises’ state of the art TGA Primary operation is looking for an...


  • Burwood Heights, Australia Motorola Solutions Full time

    **Company Overview**: At Motorola Solutions, we're guided by a shared purpose - helping people be their best in the moments that matter - and we live up to our purpose every day by solving for safer. Because people can only be their best when they not only feel safe, but are safe. We're solving for safer by building the best possible technologies across...


  • Burwood Heights, Australia Motorola Solutions Full time

    **Company Overview**: At Motorola Solutions, we're guided by a shared purpose - helping people be their best in the moments that matter - and we live up to our purpose every day by solving for safer. Because people can only be their best when they not only feel safe, but are safe. We're solving for safer by building the best possible technologies across...