Team Horizon is seeking a Sterility Assurance Lead for our Client, a global biopharmaceutical company committed to transforming lives & driving innovation.
Why you should apply:
* This is an important role, and you will be a valued part of the quality organization, acting as the owner of the sterility program for the site. You will work closely with both site and global functions.
* Generous Salary & Benefits package, as well as career development opportunities.
What you will be doing:
* Own the site's Contamination Control Strategy.
* Work closely with the operations group to develop a training program for aseptic processing.
* Provide training in aseptic behaviors and principles to the 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 site's gowning strategy.
* Establish, in conjunction with the operations function, the site's cleaning and sanitization program.
* Monitor and review microbiological data to detect trends.
* Liaise with global S&T to ensure best practices are in place with respect to sterility assurance.
* Provide technical guidance on any contamination-related non-conformances or events.
* Ensure that the site operates in accordance with governing regulations regarding sterility assurance.
* Provide technical input to the transfer of microbiological test methods to the site.
* Act as the site's sterility assurance SME during regulatory inspections.
* Through training and a purposeful presence on the operations floor, ensure that the site's practices regarding contamination control are correctly followed.
* Influence operations area owners to ensure that quality issues are identified and appropriate corrective actions are implemented to maintain compliance.
* Provide guidance to the operations functions as required to maintain a compliant and efficient relationship.
* Serve as a site SME on compliance and provide guidance on the same.
* Lead aseptic processing training and execution.
What you need to apply:
* A third-level qualification to degree level in a relevant technical discipline (science/engineering) (Microbiology qualification desirable).
* Minimum 4 years’ experience in the pharmaceutical or biopharma industry in a Quality/Operations role.
* Experience in an aseptic sterile fill finish manufacturing environment.
* Proven ability to work cross-functionally.
#J-18808-Ljbffr