Associate Sterility Assurance

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

Due to the high volume of applications we receive Job Capital are only able to respond to the candidates fitting this roles criteria. Only successfully shortlisted candidates will be contacted.

Please note that Job Capital does not accept phone enquires, so please click apply now so we can review your application.

• Flexible hours available
• More than 4 years of relevant work experience required for this role
• Work visa can be provided for this role
• Expected salary: $75,000 - $85,000 per year