Overview
Under direction from the Senior Sterility Assurance Site Lead, this role provides sterility assurance support and training for the Seqirus Liverpool site as well as all third-party manufacturing facilities that perform manufacturing activities on behalf of Liverpool. Ensures that from an aseptic perspective, the day to day manufacturing operation runs in accordance with its validated status, all SOPs, the Quality manual and Good Manufacturing Practice. Responsible for authoring and owning Environmental Monitoring trend reports, owning and facilitating aseptic training and gowning qualification, and assisting in manufacturing investigations due to microbiological excursions, such as out of specification results, objectionable organism recoveries and breaches of the sterile boundary. Associate works closely with manufacturing area managers to identify adverse trends and establish and implement corrective actions.
Responsibilities
* Under general supervision, provides support on Quality systems to ensure compliance with company standards and GMP regulatory guidelines
* Author Environmental Monitoring trend reports with detailed analysis and interpretation of the data. Ensure that all operational areas are aware of results and trends, with opportunity to contribute to root cause investigations
* Develop, maintain and improve GMP-related gowning qualification programs including standard operating procedures (SOPs)
* Support quality systems related to Validation, Deviation Management, CAPA, Change Control, and Enterprise Learning Management
* Collect, collate, evaluate, and report on Environmental Monitoring performance data of assigned business areas
* Participate in internal and external audits and assist with 3rd party supplier audits; implement continuous improvement projects
* Collaborate to resolve technical sterility assurance issues, provide aseptic training and communicate best practices
Education
* Bachelor degree in a relevant scientific discipline (Chemistry, Biology, Microbiology, etc.) or Engineering
Experience
* 3-5 years' quality systems experience in pharmaceutical manufacturing/cGMP regulated environment
* Experience of aseptic processes and sterility assurance preferred
* Knowledge of current Good Manufacturing Practices (cGMP)
* Knowledge of FDA and EMA requirements
This position is available as a 12-month secondment opportunity.
About CSL Seqirus
Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit the CSL accessibility statement.
#J-18808-Ljbffr