Sterility Assurance Concept SME
Reporting into the Sterility Assurance Lead, the Quality Sterility Assurance Concepts SME will be responsible for the leadership, oversight and life cycle management for the contamination control concept pillar governance to include: cleaning and disinfection, hygiene, operator training, gowning and behavior, facility design and process design at the site.
- Work collaboratively with the Global SA team and Local SA team to provide a holistic microbial contamination control strategy and improvement plan at the CSL Behring Manufacturing site.
- Ensure appropriate development, implementation and maintenance of sterility assurance standards and processes consistent with global governance, regulatory requirements and industry standards (quality systems, policies, procedures and work instructions).
- Collaborate with internal and external partners for the design of best practice sterility assurance controls for the microbial contamination control strategy and life cycle management – to deliver on time and to the required standards and regulatory requirements with respect to activities affecting sterile manufacturing (Fill / Finish area incl. filling, lyophilizers, sterilizers, isolator technology and auxiliary equipment, personnel training and qualification, cleaning and disinfection programmes etc).
- Support local and global capacity expansion/new projects to ensure reliable supply for our patients
- Establishment and maintenance of quality on the floor processes for critical cleanliness and aseptic behavior
- Support regulatory document submissions, internal and external (pre-approval and routine) GMP inspections as SME. Responsibility for responding to inspection observations relating to sterility assurance.
- Responsible for the generation of the documentation (IQ/OQ/PQ documents, SOPs, risk assessments, etc in the areas relating to sterility assurance, ensure compliance to GMP and that required standards are met. Ensure a harmonized appearance of all documentation across the global network.
- Ensure that global standards are met for best practice
Degree in Microbiology/biology life sciences.
- Demonstrated strong technical knowledge in the areas of sterility assurance of aseptic cleanroom facilities, their processes and equipment, and personnel to include design and use and life cycle management and cGMP compliance.
- +5 years of experience in the pharmaceutical manufacturing industry with
direct experience in sterility assurance of aseptic processing
- Extensive professional experience in leading teams with respect to aseptic cleanrooms, process, equipment, consumables, aseptic behaviors and gowning and utilities
- Demonstrated experience in quality assurance and regulatory compliance with GxP, FDA, EU and other regulatory agency guidelines.
- Experience in the manufacturing of biologics
- Direct experience executing Quality Assurance function and system within a manufacturing and QC Microbiology/Sterility Assurance context.
- Experience in interacting with regulatory authorities including submissions and inspections.
- Knowledge of auditing practices and procedures
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About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
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As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.
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