QARA Specialist

The Role

We have an exciting opportunity fora QARASpecialist to join ourQARAteam at Baxter. Reporting to theHead of QARA –ANZ,you will work collaboratively with the Operations,Quality,Regulatoryand Supply Chain teams, enablingthetimely delivery of fully compliant products and processesin linewiththe ANZ Commercial Business Plan.

With aprimaryfocus onQuality, thisqualityrole willsupporttheeffective management ofQuality ManagementSystem,with particular emphasis on thedocumentationincludingmanagementsystem andtraining.You will help ensure quality documents, records and training activities are maintained accurately, completed on time and aligned with applicable regulatory and business requirements. In addition, you will assist the QARA team with other quality activities as needed, including CAPA, internal and external audits, Field Actions (FAs),complaints, nonconforming products,supplier controlsand other quality processes that support compliance and continuous improvement.

If you are apassionatequalityprofessional looking to make ameaningfulimpact onpatients’lives, we’d love to hear from you!

Key Responsibilities

• Manageand support Quality Management Systemactivities, with a key focus on documentation management and training managementwith minimal supervision

• Maintain, update and control quality documentation, including procedures, forms, records and related quality documents, ensuring accuracy, version control, timely review and compliance with applicable requirements

• Coordinate training management activities, including trainingassignments, completion tracking, record maintenance and follow-up with stakeholders to support timely and compliant training outcomes

• Support document lifecycle processes, including document creation, review, approval, effective release, periodic review, archival and retrieval, in line with internal proceduresand systems

• Partner with cross-functional teams to promote compliant documentation and training practices and provide guidance on quality process requirements where required. 

• AssistQARAteammemberswithotheroperationQualityactivities as needed,includingCAPA, internal and external audits, Field Actions (FAs),complaints, nonconforming products,management reviews,Field Actions (FAs),quality records control,supplier controlsand other activities requiredto maintaincompliance withISO 9001and applicable quality system requirements

• Act as apoint ofcontact forenquiries relatingtodocumentation and training management .

Key Requirements

• Tertiary degree in Science or related fields

• 5or moreyears’experience working inaQualityenvironment within themedicaldevices/Pharmaindustry is desirable

• Good understanding and working knowledge of Australian,New Zealandand European UnionQualityregulations(e.g. PICs, EudraLex , other GMP regulations)

• Project management experience is highly regarded

• Highly developed interpersonal effectiveness and relationship-building abilities

• Collaborative approach and ability to work well with others. \

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