Skills & Experience:

• Demonstrated experience in microbiology within a regulated manufacturing environment.
• Practical experience working within a Quality Management System (QMS) in a complex and regulated manufacturing environment
• Understanding of GMP requirements within a regulated environment.
• Exposure to data management and interpretation of data sets.
• Excellent written communication skills, with experience authoring technical reports and quality documentation (specification and procedural based).
• Ability to work effectively in a fast-paced environment, embracing change and proactively leading initiatives that improve team performance, ways of working, and the overall working environments.
• Knowledge of relevant ISO standards (e.g., ISO 11737, ISO 11137, ISO 11135, ISO 17665), pharmacopoeia references, and FDA regulations.
• Knowledge of continuous improvement and quality assurance methods and techniques.
• Coaching and mentoring of laboratory technicians.
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