We are seeking a Sterility Assurance Lead to join our team at Client, a global biopharmaceutical company committed to transforming lives & driving innovation.
About the Role
This is an important role where you will be a valued part of the quality organization and act as the owner of the sterility program for the site. You will work closely with both site and global functions.
We offer a Generous Salary & Benefits package, as well as career development opportunities.
Key Responsibilities
* 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 concepts 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 in order 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 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 site's sterility assurance SME during regulatory inspections.
Requirements
To be successful in this role, you will need:
* 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.
* Experience in an aseptic sterile fill finish manufacturing environment.
* Proven ability to work cross-functionally.
Benefits
* Performance Bonus.
* Health Insurance.
* Pension Fund.