Tga Quality Manager

1 day ago

Allambie Heights, Australia Sunnyfield Full time

**About Sunnyfield**

Sunnyfield is an industry-leading not-for-profit organisation with 1500 employees delivering over 2000 support services daily. For almost 70 years, we have been supporting people with disability of all ages to be active, inclusive participants in their communities through innovative programs and person-centred active support plans.
Our staff are our valued partners and key to Sunnyfield’s success. As advocates of diversity, inclusivity and equality, we strive to have a team that reflects the diversity of the people we support, so their needs are met to the best of our ability.

**About the role**

You will be responsible for the effective day to day management of the Sunnyfield Enterprises Quality Management System as it relates to the processing of therapeutic products.

This is 12 months contract with the possibility of extension. Base location is Allambie Heights with some travelling involved.
- You will support the Quality team to:

- Ensure TGA facilities comply with applicable GMP standards, specifically TGA requirements and maintain regulatory licences.
- Interpret and communicate any changes that could affect Sunnyfield and proactively mitigate and resolve potential compliance issues
- Develop, implement and maintain Quality Systems to ensure high product quality in accordance with customer specifications and regulatory requirement
- Conduct program audits, coordinate relevant external customer and third party audits
- Ensure documentation of all customer complaints, deviations, corrective actions and product recalls are documented, reviewed and closed out
- Coordinate Produce Release to Client and Produce Release for Supply
- Ensure equipment and facilities qualifications are performance and validations are completed
- Ensure regular inspections to ensure compliance

**About you**

We’re looking for someone who has:

- A minimum of 5 years experience in the interpretation of cGMP legislation, regulations and procedures
- Knowledge of the cGMP and regulatory requirements relating to TGA, APVMA and HACCP
- Has experience in negotiating and managing mutually beneficial outcomes
- Tertiary qualification in Science desirable
- Well-developed in gathering information, to analyse, interpret, evaluate and inhabits creative thinking skills
- Knowledge and skills in the principles and practice of quality assurance/control and safety practice.

**Benefits**
- Salary Packaging of up to $15,900
- Career pathways
- Learning and development, including paid training
- Flexible work arrangements
- Access to professional counselling
- Discounted health insurance
- Collaborative and positive working culture, including regular wellbeing events

If you are passionate about empowering people with disability to live a life of choice, opportunity and independence and would like to work in a challenging and rewarding role, we would love to hear from you.

  • Tga Production Technician

    2 weeks ago

    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...

  • Tga Production Technician

    1 week ago

    Allambie Heights, Australia Sunnyfield Full time

    **About Sunnyfield** Sunnyfield is an industry-leading not-for-profit organisation with 1500 employees delivering over 2000 support services daily. For over 70 years, we have been supporting people with disability of all ages to be active, inclusive participants in their communities through innovative programs and person-centred active support plans. About...

  • Quality Control Associate

    4 days ago

    Allambie Heights, Australia Sunnyfield Full time

    **About Sunnyfield** Sunnyfield is an industry-leading not-for-profit organisation with 1500 employees delivering over 2000 support services daily. For almost 70 years, we have been supporting people with disability of all ages to be active, inclusive participants in their communities through innovative programs and person-centred active support plans. Our...

  • Mechanical Production Technician

    2 weeks ago

    Allambie Heights, Australia Sunnyfield Full time

    Are you mechanically minded with a passion for precision and production excellence? Join Sunnyfield Packaging Services, part of one of NSW’s most respected not-for-profit organisations supporting people with disability. Our TGA-accredited facility is seeking an experienced Mechanical Production Technician to maintain and optimise our high-performance...

  • Quality Manager

    1 day 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...

  • Product Quality Associate

    1 week ago

    Lucas Heights, Australia ANSTO Full time

    **Position Overview**: - Ongoing| Full Time | $93k - $105k +15.4% super | Salary sacrificing available - Sutherland Shire location I Flexible Work practices I Health & Wellbeing Programs - On-site Childcare for employees | Work in a campus-based community environment **About the Opportunity**: The Product Quality Associate maintains the operational...

  • Product Quality Associate

    3 days ago

    Lucas Heights, Australia ANSTO Full time

    **Position Overview**: - Ongoing| Full Time | $97k - $109k +15.4% super | Salary sacrificing available - 2 positions available | Sutherland Shire location I Flexible Work practices I Health & Wellbeing Programs - On-site Childcare for employees | Bus from Sutherland Station | free parking onsite **About the Opportunity**: The Product Quality Associate...

  • Business Development Executive

    1 week ago

    Allambie Heights, Australia Sunnyfield Full time

    **About Us** Sunnyfield operates Employment Services that specialise in providing cleanroom packaging of pharmaceutical and cosmetic products, and warehouse & logistics solutions to commercial customers whilst offering supported employment to around 60 employees with a disability. Our mission is to provide meaningful and fulfilling employment opportunities...

  • Business Development Partner

    3 days ago

    Allambie Heights, Australia Sunnyfield Full time

    **About Us** Sunnyfield is an organisation focused on people, our mission is to enrich the lives of people with disability by creating choice and control. Working together with families, friends and dedicated staff, Sunnyfield supports a brighter future for people with disability. Sunnyfield operates Employment Services that specialise in providing clean...

  • Payroll Manager

    4 days ago

    Allambie Heights, Australia Sunnyfield Full time

    **About Sunnyfield** Sunnyfield is an industry-leading not-for-profit organisation with 1500 employees delivering over 2000 support services daily. For almost 70 years, we have been supporting people with disability of all ages to be active, inclusive participants in their communities through innovative programs and person-centred active support plans. Our...