Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
Job Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
DESCRIPTION:
At Thermo Fisher Scientific, you'll join a quality assurance team focused on ensuring consistent execution of quality standards and regulatory compliance. 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 and quality review and approval of article code forms (material qualification)
- Execute change notification impact assessments; draft and approve change notification change controls
- Qualify suppliers, manufacturers and service providers
- Assist in activities within the quality agreement system
- Raise and process supplier complaints
- Assist in regulatory and client audits from readiness activities through to engagement as an SME if required
- Building and maintaining effective working relationships with key internal stakeholders from other teams and departments that foster a collaborative work environment
- Participate in implementing continuous improvement (PPI) initiatives that realise cost savings and drive efficiency
- Updating SOP’s and other documents to meet current regulatory and corporate standards
- Ownership of quality records including but not limited to deviations, CAPAs, Audit findings etc as required
- Participate in global projects and initiatives related to the remit of the Materials Management Team, as required
REQUIREMENTS:
Qualifications & Experience
- Tertiary education in science or engineering-based field (i.e. biopharmaceutical manufacture, biotechnology, process technology) or relevant validated experience
- Previous experience in the pharmaceutical industry
Skills & Attributes
- Strong knowledge of cGMP
- Desire to work in a highly dynamic, frequently changing environment with a wide variety of people and perspectives
- Ability to work independently and collaborate effectively with cross-functional teams
- Experience with quality systems and documentation including batch records, SOPs, deviations, CAPA
- Flexible and adaptable attitude
- Strong written, verbal and interpersonal communication skills
- Demonstrated ability to perform detailed documentation review and quality assessments
- Strong collaborative skills with the ability to build rapport with internal and external stakeholders
- Proficiency in quality management software systems (TrackWise, SAP, etc.) preferred
- Proficient computer skills including Microsoft Office applications
- Strong attention to detail and commitment to accuracy