Sterility Assurance Lead

Sterility Assurance Lead required for a global Biopharma who focus on discovering, developing, and delivering innovative medicines and therapies across multiple sites in Ireland. The Sterility Assurance Lead will join their site in County Sligo. This individual will be a valued part of the Quality department and will act as the owner of the sterility program on site. The individual will ensure all products leaving the site meet the standards required for marketed and/or investigational drug products.

On offer is a competitive salary and benefits package.

Key responsibilities for the Sterility Assurance Lead include:

• Own the sites Contamination Control Strategy.
• Work closely with the operations group to develop a training program for aseptic processing.
• Provide training in aseptic behaviours and principles to the ABB site.
• Establish, in conjunction with the QC Micro Lab, the clean utilities and environmental monitoring program for the site.
• Establish, in conjunction with the operations function, the sites gowning strategy.
• Establish in conjunction with the operations function, the sites cleaning and sanitization program.
• Monitor and review microbiological data in order to detect trends.
• Liaise with global S&T to ensure best practices are in place with respect to Sterility Assurance at ABB.
• Provide technical guidance on any contamination related non-conformances or events.
• Ensure that the site is operating in accordance with governing regulations with respect to Sterility Assurance.
• Provide technical input to the transfer of microbiological test methods to the site.
• Act as the sites’ Sterility Assurance SME during regulatory inspections.
• Through the use of training and a purposeful presence on the operations floor, ensuring that the sites practices with respect to contamination control are being correctly followed
• Expected to influence operations area owners to ensure that quality issues are identified and appropriate corrective actions are implemented to maintain compliance.
• Provides guidance to the operations functions as required to maintain a compliant efficient relationship.
• Is a site SME on compliance and provides guidance on same.
• Lead aseptic processing training and execution

The required skillset to be the successful candidate includes:

• A Third level qualification to degree level in a relevant technical discipline (science/engineering) (Microbiology Qualification desirable)
• Minimum 4 years’ experience in the pharmaceutical industry or biopharma industry in Quality/Operations role
• Minimum 1 years’ experience in an aseptic sterile fill finish manufacturing environment.
• Minimum 1 years’ experience in a microbiological function in an aseptic sterile fill finish facility.
• Proven ability to work cross-functionally.