When your part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation.
D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
Position Summary :
Provide day to day management of Quality Assurance activities and Quality Management System at Microbiology Perth to ensure that Quality Systems and products are effective and in compliance with regulatory expectations and quality standards.
The position holder will report to the Quality Manager.
What will you do?
Key Responsibilities :
Ensure compliance and assist in the audits (pre audit and post audit follow up to external (regulatory) requirements, including Quality Management Systems (ISO 13485 : 2016, ISO 9001 : 2015) and the In Vitro Diagnostics Directive.
Ensure corrective actions are implemented for issues arising from the audits.
Responsible for reviewing and approving SOPs in line with change process.
Ensure that general day to day activities such as batch release, approval of manufacturing documentation including technical reports, review / approval of non-conformances, deviations, reviewer / approver for SOP’s and briefs
Process, monitor and track change control and ensure all requirements are met and complete.
Undertake QA responsibilities regarding vigilance (failure investigations, recall investigations, risk assessments and field actions, ensuring all necessary review are timely documented and completed.)
To act as coordinator and / or QA Representative on Non-conformances investigations and CAPA.
Over see the internal audit program and perform internal audits to ensure compliance to external regulatory requirements.
Provide metric data for Monthly Management meetings and Management Review and data trend analysis.
Review and sign off for validation files from a QA perspective
Ensure training program for Quality functions and relevant documentation is up-to-date. To lead in Quality training for the site
Assist in training for Quality functions and relevant documentation in up-to-date
Support Risk Management meetings, generating PMS reports and Verification of effectiveness.
Any other duties / projects as are reasonable and within the skills and ability of the post-holder.
Provide quality support the business.
Any other tasks / duties deemed to be within the competence of the post-holder.
Supports PPI and other Continuous Improvement activities
Act as deputy for the Quality Manager for Quality Systems & Assurance roles with support from Quality Director Europe, when required.
Who we are looking for :
Minimum Requirements / Qualifications :
Degree in Scientific or related field / or equivalent experience.
Proven experience in a QMS role preferably within MDD / IVD
High attention to detail
Ability to communicate openly
Work flexibly to ensure deadlines are met
Experience with writing concise / accurate reports
Competent in the use of the MS Office suite
Preferred Qualifications :
Experience in audit involvement.
Usage of SAP or related system
Experience of working with ISO 17025 accreditation systems.
About us :
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer.
Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon
With Thermo Fisher Scientic, it’s not just a career. It’s a chance to realise your best professionally and personally.