Milo Steeden
Quality Manager @4basebio
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WORK HISTORY
Quality Manager @4basebio
Joined as part of a small team, growing with time, to aid the development of the commercial arm of the business into a GMP manufacturing entity. Accreditation was achieved within 3.5years on our first inspection.• Designed structure & framework of the QMS, championing its adoption by senior leadership• Aided the development of various elements of the QMS, supporting members of the team less familiar with the practices and principles of GMP.• Oversight of technical system qualifications such as; manufacturing and laboratory equipment, cleanrooms, laboratories, warehousing facilities and environmental monitoring systems along with developing the necessary policies, procedures and protocols to do so.• Actively involved in the identification, investigation and resolution of Quality Events, change controls and CAPA management.• Promoting a culture of Quality & Compliance• Main Achievementso GMP accreditation obtained on first inspection (teamwork)o Over 400 items of equipment onboarded, commissioned and qualifiedo 2 cleanroom facilities qualifiedo 2 EMS systems configured, commissioned and qualified
EDUCATION
Loughborough University
BSc (Hons) Chemistry with Analytical Chemistry, Analytical Chemistry
Hugh Christie School
A, A(O) and GCSE's
SKILLS
ABOUT MILO STEEDEN
An ambitious Quality Professional with a \'can do\' approach and a proven track record working within the pharmaceuticals and medical device industries. Qualified in Chemistry with Analytical Chemistry, with a core foundation of experience in Quality Control, Quality Assurance and Business Process Improvement.A facilitator of change and continuous improvement, attention to detail and experience of working closely with cross-functional managers and their teams, locally and internationally, to raise the importance and awareness of quality, governance and best practice.Previous line management responsibilities, including performance management and coaching, and highly adept in the use of various tools and methodologies which support change and process initiatives.Specialties: • Experience with Commercial, API & medical device product manufacturing• Quality Management Systems• Validation Lifecycle activities; C&Q of equipment and process validation• Laboratory Investigations, Deviations and CAPA management• Business Process Improvements (LEAN)• Kaizen & Value Stream Mapping• Root Cause Analysis & Testing• Training & KPI Monitoring• Leadership & Coaching
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