Biopharmaceutical Contamination Control Specialist
3 days ago
Overview
Thermo Fisher Scientific, a leading global biotechnology company, is seeking an experienced Contamination Control Manager to join our Brisbane site - Patheon Pharma Services.
We offer a competitive salary of $120,000 - $180,000 per annum, depending on experience.
About the Role
This key position is responsible for developing and implementing the contamination control strategy to ensure regulatory compliance and maintain product quality.
The ideal candidate will have a strong understanding of microbiology and contamination control requirements for biological products and biomanufacturing processes.
Key Responsibilities
Develop, own, and collaborate to build the contamination control strategy ensuring regulation compliance and bringing to bear industry expertise and ongoing updates for regulators and clients;Lead all aspects of the efficiency of the Environmental Monitoring system including the trend analysis, identify any weaknesses and initiate any required improvements;Assist with regulatory inspections and client audits, including as a front room for SME;Oversee and support the microbial control strategy, approach and implementation for PPQ and commercial production;Adequate trend analyses are carried out from the environmental monitoring data for viable and non-viable particles;Report status of and promote Contamination Control within the Senior Leadership Team;Lead, mentor and empower members of the environmental action committee;Provide technical input into relevant quality investigations (e.g., deviation, CAPA atypical, Out of Specification and Out of Trend investigations to ensure swift resolution and recommending appropriate corrections;Implement practical application of the Quality System, Change Control, Deviations, CAPA, OOS and OOT, Document Management, related to the Quality Control Department.Requirements
To be successful in this role, you will need:
- At least 10 - 15 years' industry work experience within the biopharmaceutical and/or pharmaceutical sector aligned to microbiology fields;
- Demonstrated experience leading teams to develop and implement core strategies, policies and processes;
- Strong working knowledge in c GMP policies and practices;
- Established experience in microbiology theory and technical expertise with microbiological analysis;
- Experience with regulatory inspection practices through direct agency engagements;
- Ability to work optimally in a highly multifaceted environment with a wide diversity of people and perspectives;
- Ability and effectively to work on multiple tasks and projects simultaneously with an approach that values continuous improvement;
- Good knowledge of Microsoft applications (Excel, Word, Outlook, Power Point) and Smartsheets.
Benefits
We offer a range of benefits to support your career development and well-being, including:
- Flexible work arrangements;
- Generous leave policies;
- Opportunities for professional growth and development;
- A supportive team environment;
- Access to online courses via Thermo Fisher Scientific University Plus and Linked In learning.
About Us
Thermo Fisher Scientific is a leading global biotechnology company dedicated to enabling our customers to make the world healthier, cleaner and safer. Our mission is to accelerate research, solve complex scientific challenges and drive technological innovation. We value integrity, intensity, innovation and involvement, and we strive to create a diverse and inclusive workplace culture.
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