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Tga quality manager

Sydney
Sunnyfield
Quality Manager
Posted: 12 September
Offer description

**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.

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