Lisa Hellier, Cqp Mcqi Email & Phone Number

Hinxton, England, United Kingdom

Supporting Cellular Operations and the Genomic Surveillance Laboratory Platform on their Quality Management journey. Focused on embedding a culture of quality and compliance through the successful implementation of the Scientific Operations Quality Policy and the introduction of a formal Quality Management System (QMS).Key achievements include:- Providing.

London, United Kingdom

• Achieved acccreditation to ISO 9001:2015 over a year ahead of schedule.
• CAPA and investigation lead.
• Introduction of Quality training units for all staff to improve documentation practice and compliance.
• Complaint and internal audit management to ISO 9001.
• Ensuring compliance with ICH-GCP and update to ISO 9001:2015 standards.
• Coordination of external assessments by sponsors and agencies such as the MHRA.

Dartford, United Kingdom

Leading a team of 12 technicians and manage the manufacture of antibodies and antigens using mammalian cell culture techniques. Focus on resource management, quality, compliance and process improvement. Facilitating the introduction of new processes and design changes into routine manufacturing.Control of environmental parameters (i.e. microbial load in.

Dartford

Working in the Quality Assurance department my responsibilities included incoming raw material approval, final product sign-off, internal and external audit support (FDA, TUV), documentation updates and new product release.

Dartford, United Kingdom

Assisting in the transfer of diagnostic products from the US to the UK. Highlighting potential problems, assessing and proofreading manufacturing paperwork. Processes to review are fermentation, purification and QC testing.

Developing immunodiagnostic kits including latex agglutination and ELISAs as a part of the R&D team.Greatest success: Taking on sole responsibility for the final phase of product development. The product launch of the first new kit developed on site, a latex agglutination assay for the identification of Streptococci.Additional roles: Head of the Social.

Manufacture and Quality Control of immunodiagnostic kits (ELISA, Immunofluorescence tests) and molecular kits (PNA, FISH). I joined the company on a temporary contract to gain work experience during the summer break of my university course. During that time a position as a manufacturing technician became available and I decided to permanently move to.

Proof reading of both German and English press releases. Alone responsible for organising and filing articles and advertisements relating to two major museums in Vienna (Mozart House, Jewish Museum), showing attention to detail and handle documentation in a neat manner.

Vienna, Austria

Translation of English and German scientific texts including Information for Use leaflets and risk assessment certificates for immunodiagnostic products.

Msc, Medical Diagnostics, 70% Average

Activities and Societies: MSc Medical Diagnostics expected finish: Sept 2012 Cranfield University, Cranfield Part-time course while.

Bsc (Hons), Microbiology, 2.1

Activities and Societies: Volleyball teamPart-time course while working full-time. Modules such as Laboratory Techniques for Biomedical.

Food Science And Biotechnology

Education record