Sterility Assurance Monitoring Controls SME
Company: Disability Solutions
Location: Kankakee
Posted on: January 23, 2023
Job Description:
Job Description
- 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 validation 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) to include EMPQ, media fill
simulations programme, container closure integrity programme,
bacterial filter validation and disinfectant validation
- 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 validation, 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 withdirect 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
proceduresAbout UsOur BenefitsWe encourage you to make your
well-being a priority. It's important and so are you. Learn more
about how we care at CSL.About CSL BehringCSL 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 .We want CSL to reflect the world around
usAs a global organisation with employees in 35+ countries, CSL
embraces diversity, equity and inclusion. Learn more about
Diversity, Equity & Inclusion at CSL.Do work that matters at CSL
Behring!
Keywords: Disability Solutions, Joliet , Sterility Assurance Monitoring Controls SME, Other , Kankakee, Illinois
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