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Associate Sterility Assurance

2 weeks ago

Sydney, Australia Job Capital Full time

Our client is seeking an experienced Associate Sterility Assurance Officer

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 practice

Training - 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

**Job Types**: Full-time, Subcontract

**Salary**: $75,000.00 - $85,000.00 per year

**Benefits**:

- Visa sponsorship

**Education**:

- Bachelor Degree (required)

**Experience**:

- Relevant: 3 years (required)

Work Location: In person