Sterility Assurance Lead

Position Overview

We are seeking a Sterility Assurance Lead for a prominent pharmaceutical company located in County Waterford, Ireland. This role presents an opportunity to significantly influence sterility assurance practices by managing and enhancing all contamination control and sterility-related processes at the site. The initial contract is for 12 months with a potential to extend based on performance and project needs.

Primary Responsibilities

• Designing and implementing strategies in contamination control, media fill processes, environmental monitoring, decontamination procedures, sterilisation, and depyrogenation.
• Leading critical investigations concerning sterility assurance and offering expert advice on pertinent projects.
• Reviewing technical documentation linked to commissioning, qualification, process validation, and compliance with regulatory standards in sterility assurance.
• Playing a key role in developing personnel qualification programs, including their training and development in sterility assurance principles.

Required Qualifications and Experience

• An honours degree in Microbiology is essential.
• Demonstrable experience working in sterility assurance within the pharmaceutical or a related sector.
• Hands-on knowledge of contamination control, environmental monitoring, and sterilisation processes is required.

Additional Information

This role emphasizes critical competencies such as sterility assurance, contamination control, environmental monitoring, and sterilisation aligned with pharmaceutical quality standards, including cGMP. Key terms associated with the position include microbiology, quality assurance, process validation, and cleaning validation among others.

Equal Opportunity Statement: The hiring organization promotes equal opportunity employment and welcomes candidates who fulfill the role requirements.