Product Release Associate & EBD Administrator
A great opportunity has become available for a Product Release Associate & Electronic Batch Documentation System (EBD) Administrator at Baxter...
Summary about this job
Quality Assurance & Control
Company: Baxter Healthcare Pty Ltd
Location: Sydney
Work type: Full Time
Salary: n\a
Phone: +61-8-6146-8097
Fax: +61-2-7757-3541
E-mail: n\a
Site: n\a
Detail information about job Product Release Associate & EBD Administrator. Terms and conditions vacancy
About Baxter
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anaesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
What You’ll Be Doing
A great opportunity has become available for a Product Release Associate & Electronic Batch Documentation System (EBD) Administrator to join our Baxter Quality Assurance team in a permanent position, reporting to the QA Manager – Manufacturing in Old Toongabbie, NSW. The main purpose of this position is to ensure documented batch information meets cGMP requirements, you will be the delegated authorised person for release for supply per TGA Guidance, ensuring maintenance and improvement of key systems within the manufacturing process and the Administrator of EBD.
Product Release
• Release to the appropriate standard and in a timely manner of locally manufactured products & other rework items to meet the company’s production schedule
• Release of temperature sensitive shipments and imported products as required
• Improve key processes in the production environment (i.e. support in GDP and GMP training, as required)
• Sharing of information with team members
• Ensure adequate review and approval of release procedures
Electronic Batch Documentation (EBD) System
• Manage and administer the EBD system including coordinating changes and improvements
• Creation and update of EBD templates
• Become a SME in EBD
• Provide support to manufacturing in the use of EBD and the requirements of EBD completion to GDP and GMP requirements
• Support EMS Principles
Qualifications
Do you have what it takes to build a career here?
Qualifications
Essential Skills and Qualifications
• Background in Quality Assurance processes
• Demonstrated application of GDP in a pharmaceutical manufacturing environment
• Effective verbal and written communication skills
• Able to relate well to all levels of employees
• Negotiation skills with ability to operate in a team environment
• Aptitude using electronic systems similar to EBD
Desirable Skills and Qualifications
• Experience with electronic systems similar to EBD
• Previous experience in product or material release
Why Baxter?
A Career That Matters
Baxter’s employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.
Apply today and experience a career that matters! Applications close 27th July 2018.
Baxter is an equal opportunity employer and makes employment decisions without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other status protected by law.