Solina Dangleben Email & Phone Number

Godmanchester, Gb

Cambridge, England, United Kingdom

Assist the Director of Product Management in supervising the execution of daily takes following set priorities. Ensure all H&S procedures and policies are implemented and adhered to concerning the department. Highlight any gaps and training needed for team members to the Director of Product Management. Maintain product validation and verification records. Ensure all required national and international standards and legislation are implemented and adhered to concerning the department, including ISO 13485:2016/EN ISO 13485:2012, ISO 9001:2015, EN14885, MDSAP and others as applicable. Participate in third-party supplier auditing that impacts product microbiological integrity. Apply microbiological expertise toward Corrective Actions and Preventative actions for product non-conformities. Build, communicate and execute microbiological test plans for all Design Projects according to the approved process to ensure all products comply with industry-required norms and test methods. Undertake market research, critical analysis of competitor products, and maintain a state-of-the-art understanding of regulatory requirements about microbiological verification, emerging technologies in infection control, validation and microbiology of medical devices and biocides.

Cambridge, United Kingdom

Ensuring that all required national and international standards and legislation are implemented and adhered to concerning the department, including ISO 13485:2016/EN ISO 13485:2012, ISO 9001:2015, EN14885, MDSAP and others as applicable. Identify, communicate, and coordinate appropriate testing requirements for both design and design change projects for PT2 Disinfectants. Proposed microbiological test plans for existing products to ensure continuity of state-of-the-art status. Collaborated with cross-functional development teams in early development work by commissioning early verification tests and building experimental test methods. Applied microbiological expertise toward product label claims based on microbiological verification tests. Applied microbiological expertise toward designing and developing Class IIa and IIb medical devices. Implemented SOPs and work instructions to improve microbiological surveillance during and post-manufacturing of Class I sterile medical devices. Perform market research and maintain a state-of-the-art understanding of regulatory requirements for microbiological verification and emerging technologies within the scientific communityabout PT Disinfectants. Communicate regulatory requirements for microbiological verification knowledge to aid sales, product development and customer communications.

Ware, Hertfordshire, United Kingdom

Perform microbial analysis of finished products to support Pharmaceutical manufacturing and environmental monitoring. Participate in early development work by performing microbial analysis of raw materials and intermediates. Communicate microbial analysis results in an accessible manner to the wider company. COSHH and Risk Analysis Assessor Write and review Laboratory Analytical Methods used for onsite microbiological analysis. Generating Product Test Reports.

Basingstoke, Hampshire, United Kingdom

Perform real-time and post-expiry stability testing of products to ensure they remained fit for purpose during product shelf life. Perform simulated transportation and temperature testing of products to ensure products could withstand temperature variations experienced during transportation. Generate product reports and maintain product validation records.

Cambridge, United Kingdom

Worked with a diverse team in ensuring product availability for customers and helped to maintain the Asda standard of "Happy to Help" customer service with a smile.

Master’S Degree, Biomedical Sciences (Medical Microbiology)

Bachelor'S Degree, Microbiology, General, 2.1

Graduated with Honours in Microbiology.