Head of Sterility Assurance and Microbiology
Elusav Recruitment has an amazing opportunity for a Head of Sterility Assurance and Microbiology with a leading global biopharma company in Waterford, Ireland.
Responsibilities:
* Develop and implement comprehensive sterility assurance and microbiological programs in alignment with the organizational strategy, vision, and objectives.
* Ensure the compliance of products and processes with applicable sterility assurance and microbiology regulatory requirements and company quality standards.
* Maintain a system to ensure sterility assurance and microbiological risks are properly identified, tracked and mitigated.
* Oversee, with Q&V team, the validation, qualification and monitoring of methods, equipment and the environment ensuring sterility assurance control.
* Follow metrics and monitor data for the sterility assurance and microbiological activities, to identify trends and issues and to implement action plan.
* Promote a culture of quality throughout the organization, identifying and driving continuous improvement initiatives and projects to enhance the sterility assurance and microbiological activities.
* Evaluate and recommend new technologies, tools, and methods to enhance sterility assurance and microbiology.
* Lead management reviews to assess the effectiveness of the sterility assurance program and microbiological program.
* Lead and manage the sterility assurance and microbiology team, including hiring, training, coaching, professional development and performance evaluation.
* Interact with external bodies & Global Quality to bring knowledge and awareness of best industry practices.
* Prepare and participate in regulatory inspections and audits, providing expertise on sterility assurance and microbiology.
Requirements:
* Degree and/or Master’s in a science or engineering discipline.
* Over 7 years of experience in the Pharma industry, with at least 4 years in a leadership role within aseptic/sterile manufacturing or Microbiology.
* Proven experience in microbiology and sterile manufacturing.
* Strong leadership and experience in developing and mentoring technical teams.
* Expertise in aseptic manufacturing, regulatory requirements and product technical transfer.
* Strong communication, decision-making, and analytical skills.
* Proficient in Lean Principles and process control strategies to enhance operational effectiveness.
Contact:
If you would like to learn more about the vacancy, apply now, or contact Brendan Mullins on +353 61 527 150 or Bmullins@elusav.com
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Science and Engineering
Industries
Pharmaceutical Manufacturing
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