Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

At Thermo Fisher Scientific, each one of our 75,000 outstanding minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer!

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. Surrounded by collaborative colleagues, you’ll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an outstanding strategy for the near term and beyond. Take your place on our strong team, and help us make significant contributions to the world.

Position Summary:

Manufacturing of biopharmaceutical products is required to be in compliance with international quality requirements as defined by TGA, FDA, EMA, ICH etc.  This role reports to the Materials Management Team Leader, and is based in Brisbane. The roles main focus is to support the Materials Management Team in maintaining the material quality and compliance systems across the Brisbane site.

Key Responsibilities:

Drafting article code formsComplete change notification impact assessments; draft and approve change notification change controlsAssist in activities within the quality agreement systemAssist in regulatory and client audits from readiness activities through to engagementBuilding and maintaining effective working relationships with key internal collaborators from other teams and departments that foster a collaborative work environmentParticipate in implementing continuous improvement (PPI) initiatives that realise cost savings and drive efficiencyUpdating SOP’s and other documents to meet current regulatory and corporate standardsOwnership of quality records including but not limited to deviations, CAPAs, Audit findings etc as requiredParticipate in global projects and initiatives related to the remit of the Materials Management Team, as requiredPerform any other legitimate duties as required by the Materials Management Team Leader

Frequent Contacts:

Internal

QC, USP, DSP, MBP, WHS and Supply Chain

External

Suppliers, Contractors

Minimum Requirements/Qualifications:

Qualifications & Experience

Tertiary education in science or engineering-based field (i.e. biopharmaceutical manufacture, biotechnology, process technology) or relevant validated experiencePrevious experience in the pharmaceutical industry

Skills & Attributes

Good knowledge of cGMPDesire to work in a highly dynamic, frequently changing environment with a wide variety of people and perspectivesFlexible and adaptable attitudeStrong written, verbal and interpersonal communication skillsStrong collaborative skills with the ability to build rapport with internal and external customers

Other Job Requirements:

Adhere to OHS policies and procedures and ensure a safe and healthy workplace environmentAdhere to the Chain of Responsibility obligations under the Australian Heavy Vehicle National Law

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.