14 Sep
|
Baxter
|
New South Wales
14 Sep
Baxter
New South Wales
Job Description
This is where your work makes a difference.
n
At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.
n
Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.
n
Here, you will find more than just a job-you will find purpose and pride.
n
The Role
n
We are seeking a motivated and detail-oriented Quality Assurance Associate to join our Quality team at our Toongabbie manufacturing facility.
n
Responsibilities
n
n
- Ensure each batch document is thoroughly reviewed for compliance prior to releasing batch to the market
n
- Ensure each complaint is properly reviewed and investigated, and closed in timely manner following with Global Quality Policy and applicable Regulatory requirements
n
- Perform trend analysis of complaints and waste/scraps and work with Manufacturing team to implement continuous improvement/complaint & waste/scrap reduction
n
- Ensure proper root cause analysis is performed when a trend of Customer Complaint is received or a deviation is reported in MPI database
n
- Ensure proper root cause analysis in Non-Conformance Reports (NCRs)
and Manufacturing Process Improvements (MPIs) to continuously improve Right First Time performance
n
- Manage Manufacturing Non-Conformance Reports (NCRs) and Manufacturing Process Improvements (MPIs) to ensure they are adequately written, closed in timely manner and all associated CAPAs are implemented
n
- Provide inputs for Monthly Indicators, Management Review, and Annual Product Review
n
- Support Release Department as needed.
n
n
Key Requirements
n
n
- A Tertiary degree in Pharmacy, Science, Engineering or related fields
n
- Proven experience in Sterile Manufacturing and/or Quality Assurance processes
n
- Strong understanding of regulatory requirements and quality standards
n
- Outstanding attention to detail and analytical skills
n
- Excellent communication and teamwork abilities
n
- Proficiency in quality management software and tools
n
- Ability to strictly adhere to deadlines and manage multiple tasks simultaneously
n
- Outstanding communication and collaboration skills.
n
n
Equal Employment Chance
n
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.
n
Reasonable Accommodations
n
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process.
📌 Quality Assurance Associate (New South Wales)
🏢 Baxter
📍 New South Wales