Senior Manager Sterility Assurance is required by CareerWise Recruitment for our Galway based client. This is a Senior role that requires an in-depth understanding of Microbiological principles as they apply to Sterility Assurance. Suitable if you have a pure Microbiology background and bring extensive hands‑on experience in Sterility Assurance.
Senior Manager Sterility of Assurance plays a pivotal role in ensuring the Sterility of Injectable Products through robust Contamination Control and Sterility Assurance Strategies. This role extends beyond Microbiological Testing to encompass comprehensive Oversight of Aseptic Manufacturing, Contamination risk management, and adherence to global Regulatory Requirements. It involves close collaboration across departments to drive sterility assurance initiatives while fostering a culture of Quality excellence.
THE ROLE
Lead the site Sterility Assurance strategy and program, ensuring compliance with EU GMP Annex 1 and global regulatory requirements.
Develop and maintain the Contamination Control Strategy (CCS) to support sterile manufacturing operations.
Conduct risk assessments for aseptic processes, environmental monitoring, and container closure systems to mitigate contamination risks.
Oversee and continuously improve the environmental monitoring program to ensure robust contamination control.
Lead and support microbiological investigations, ensuring appropriate root cause analysis and effective CAPA implementation.
Coordinate and oversee aseptic process simulations (media fills) and support review and approval of related documentation.
Support validation and qualification activities related to sterility testing, aseptic processes, and laboratory systems.
Represent sterility assurance in internal and external audits and regulatory inspections, addressing observations and driving corrective actions.
Collaborate cross‑functionally with Quality, Manufacturing, Engineering, and Microbiology teams to ensure alignment on sterility assurance practices.
Maintain and approve key sterility assurance documentation, including SOPs, validation protocols, and contamination control plans.
Monitor and report sterility assurance performance metrics and trends, driving continuous improvement across the site.
REQUIREMENTS
A Bachelor’s Degree (or higher) in Microbiology or a closely related field (e.g., Biotechnology).
Extensive years of experience in Sterility Assurance, Aseptic Manufacturing, or a related field, with a strong emphasis on Microbiology and Contamination Control is needed.
Aseptic Process Expertise:
Proven experience in contamination control strategies, including cleaning and disinfection validation.
Hands‑on experience with isolator technology, environmental monitoring, and aseptic processing validations…
Deep understanding of Annex I, US, and EMA GMP regulations and their application in sterility assurance
Hands‑on experience in regulatory audits, with a solid track record of compliance and audit readiness in sterile environments.
Strong ability to mentor and develop teams, lead investigations, and drive sterility assurance initiatives.
Risk Assessment & Problem‑Solving : Experience in sterility‑related risk assessments, deviation investigations, and implementing corrective/preventive actions.
Technical Proficiency : Proficient in the use of contamination control tools and monitoring systems, including MODA, Excel, and project management software.
Communication & Collaboration : Excellent ability to articulate sterility assurance concepts and collaborate cross‑functionally to drive compliance and process improvements.
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