Our client based in Victoria is looking for a Senior Associate to work in the sterility assurance team.
Reporting into the Sterility Assurance SME, the Associate / Senior Associate, Sterility Assurance will be
responsible for the oversight and life cycle management of Sterility Assurance controls governance, validation controls and monitoring controls 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 our clients
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 sterility assurance controls, validation and
monitoring activities as directed by the Sterility Assurance SME or Site Leader
•Support local and global capacity expansion/new projects to ensure reliable supply
for our patients
•Support regulatory document submissions, internal and external (pre-approval and
routine) GMP inspections as directed by the Sterility Assurance SME or Site
Leader.
•Responsible for the generation of the documentation (IQ/OQ/PQ documents for
microbiological method validation (sterility testing, bioburden and endotoxin),
SOPs, risk assessments, trend reports, objectionable organism review, alert and
action in house limit review etc. to ensure compliance to GMP and that required
standards are met. Ensure a harmonized appearance of all documentation across
the global network.
•Support the local site in any deviations related to microbial contamination.
•Ensure that global standards are met for best practiceTraining
•Delivery of aseptic training and processes to value stream production partners
Education A minimum of a Bachelor Degree in Microbiology/Biology life sciences or equivalent
qualification or experience.
Experience
•Demonstrated strong technical knowledge in the areas of sterility assurance of
aseptic cleanroom facilities, their processes and equipment, to include design,
validation and monitoring, life cycle management and cGMP compliance.
•Minimum +3/+5 (Associate/Senior Associate) years of experience in the
pharmaceutical manufacturing industry with direct experience in sterility assurance
of aseptic processing
•Extensive professional experience with respect to aseptic cleanrooms, processes,
equipment, validation, microbial monitoring, aseptic behaviors and gowning.
•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
Reporting into the Sterility Assurance SME, the Associate / Senior Associate, Sterility Assurance will be
responsible for the oversight and life cycle management of Sterility Assurance controls governance, validation controls and monitoring controls 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 our clients
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 sterility assurance controls, validation and
monitoring activities as directed by the Sterility Assurance SME or Site Leader
•Support local and global capacity expansion/new projects to ensure reliable supply
for our patients
•Support regulatory document submissions, internal and external (pre-approval and
routine) GMP inspections as directed by the Sterility Assurance SME or Site
Leader.
•Responsible for the generation of the documentation (IQ/OQ/PQ documents for
microbiological method validation (sterility testing, bioburden and endotoxin),
SOPs, risk assessments, trend reports, objectionable organism review, alert and
action in house limit review etc. to ensure compliance to GMP and that required
standards are met. Ensure a harmonized appearance of all documentation across
the global network.
•Support the local site in any deviations related to microbial contamination.
•Ensure that global standards are met for best practiceTraining
•Delivery of aseptic training and processes to value stream production partners
Education A minimum of a Bachelor Degree in Microbiology/Biology life sciences or equivalent
qualification or experience.
Experience
•Demonstrated strong technical knowledge in the areas of sterility assurance of
aseptic cleanroom facilities, their processes and equipment, to include design,
validation and monitoring, life cycle management and cGMP compliance.
•Minimum +3/+5 (Associate/Senior Associate) years of experience in the
pharmaceutical manufacturing industry with direct experience in sterility assurance
of aseptic processing
•Extensive professional experience with respect to aseptic cleanrooms, processes,
equipment, validation, microbial monitoring, aseptic behaviors and gowning.
•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
