Quality Systems Specialist

4 days ago

Old Toongabbie, Australia BAXTER Full time

**This is where you save and sustain lives**

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

**About Us: Baxter's Mission**:
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

**The Role**: Quality Systems Specialist ANZ**

Reporting to the Snr Quality Systems Manager ANZ / CIVA / PR, you will be providing Quality Systems support to ensure a compliant, efficient Quality Management System (QMS) is optimally and consistently implemented across all 7 ANZ compounding sites with scope to support CIVA & PR, all in accordance with local regulatory requirements for Good Manufacturing Practice and Baxter Global requirements. This is a Full Time, Permanent position available at out Old Toongabbie Site.

**Key Responsibilities**:
To ensure effective implementation of the Quality Management System in all ANZ Compounding Facilities, in compliance with Global and local Regulatory requirements, including:

- Execution of Primary QMS activities - Supplier Quality/ Vendor Management, Documentation Management, with support also to Product Complaints, Annual Product Quality Reviews & Regulatory Licence processing.
- Leverage integrated databases (data collection, coordination & analysis) of Quality KPIs/Metrics, Review Boards and Management Reviews.
- Own the Supplier Quality, Documentation Management impacting Quality Systems for ANZ Compounding, including Project Management and execution of QS-related tasks.
- Provide training for operational and quality personnel on Quality Systems related topics as the need arises.
- Participate in Internal, Corporate and Regulatory Inspections as required, including coordinating relevant follow-up. Maintain the tracking and review of commitment dates.
- Drive and support improvement and standardization of the QMS, including coordination of continuous improvement activities.
- Other duties in support of Compounding Quality Systems as required, including support to Regional/Global Compounding.

**Essential Skills and Qualifications**:

- Tertiary science degree, preferably in Chemistry, Biology, Microbiology, Engineering discipline or a Pharmacist in a manufacturing environment.
- 4+ years proven experience working within a **GMP-regulated manufacturing environment (pharma, medical devices)**, preferably **Sterile Manufacturing/Aseptic Compounding.**:

- Knowledge of Quality Management Systems in healthcare, including development, implementation and ongoing execution and continuous improvement and specific experience in: CAPA, Supplier Quality Management, Complaints, Recalls, Validation
- Experience in Data Collation and Analysis
- Highly developed verbal and written communication skills
- Ability to operate in a team environment, across all levels of the organization.
- Customer-focused with high level of initiative and energy.

**Equal Employment Opportunity**:
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

**EEO is the Law**:
EEO is the law - Poster Supplement

Pay Transparency Policy

**Reasonable Accommodations**:
**Recruitment Fraud Notice**:
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

**Reasonable Accommodations**

**Recruitment Fraud Notice**

Baxter has discovered incidents of employmen

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