Description:
This position will be a standalone role (initially anyways) as an SME regarding sterility assurance with extensive stakeholder management responsibilities. and will establish the sterility assurance programme from the ground up for a Drug product perspective. The organisation do have established process in place from their established drug substance operations already, but really need someone with strong DP background. This person will be the sterility assurance SME for the company, and representative for FDA/HPRA from audit/regulatory perspective. The role will have great exposure across the entiriety of the organisation, and will work in both a direct and global capacity.
- Strategic Leadership: Own and continuously evolve the site’s Contamination Control Strategy, ensuring alignment with global standards and regulatory requirements.
- Regulatory Compliance & Influence: Implement regulatory expectations, maintain compliance with EU GMP Annex 1, 21 CFR, USP, EP, JP, and ICH guidelines, and stay current with emerging regulations and best practices.
- Training & Culture: Design and deliver robust training programs on aseptic processing, behaviors, and contamination control principles to embed a culture of sterility assurance across the site.
- Environmental Monitoring & Utilities: Establish and maintain environmental monitoring and clean utilities programs, ensuring proactive contamination control.
- Technical Expertise: Provide expert input on gowning, cleaning, sanitization strategies, microbiological method transfers, and contamination investigations.
- Investigations: Lead and guide the investigation of contamination-related deviations, non-conformances, and sterility failures. Perform root cause analysis, define corrective and preventive actions (CAPAs), and ensure timely closure of quality events. At the Shanbally site and within Global Operations.
- Data Analysis & Risk Mitigation: Review microbiological data trends, identify risks, and implement effective mitigation strategies.
- Global Collaboration: Partner with global Technology and Quality functions to ensure site alignment with industry best practices and BioMarin network standards.
- Continuous Improvement: Drive initiatives to enhance microbiological quality, operational efficiency, and inspection readiness.
- Facility Expansion Support: Lead microbiology aspects of facility expansions, including cleanroom qualification and sterilization systems.
Requirement:
- 5 + Years experience working within Microbiology/sterility Assurance role
Well versed in Annex 1 regulations and proven experience in implmentation of contamination control strategies and regulatory requirements regarding sterility Assurance on a drug product site.