Biotech quality assurance and systems experience with specialist knowledge in clinical trial oversight and computer system validation
Quality Assurance
Project & Program Management
Regulatory Affairs
Diligence & Business Strategy
Lyndsey joined Dark Horse in 2021, bringing prior experience in small and medium sized biotech with a focus on quality assurance alongside computer system validation and implementation.
For DHC clients, Lyndsey has performed not only quality assurance projects but training and project management as well. Her experience with GMP- and GCP-compliant computer systems supports QA and QC projects from the ground up. Her experience has provided particular insight into the challenges that younger companies experience when setting up compliant computer systems and validation.
Lyndsey’s career started at Circassia where she joined in document control gaining important experience in the different GxPs. As well as being the system owner for the eDMS, she was also involved in the generation and management of many document types including SOPs, Issues, CAPAs, Protocols, and Reports. During this time she gained auditing experience and an IRCA auditing qualification.
Lyndsey then transitioned onto a computer system-focused role within the company where she was the implementation lead on an eQMS system consisting of Complaints, CAPA/Non-conformance and Change Control processes that covered pharmaceuticals, medical devices and combination products. She led the workflow development, managed system design with the vendor, and was responsible for the validation project.
Lyndsey then moved on to PsiOxus Therapeutics. Here she was responsible for supporting the clinical operations function ensuring GCP was implemented for Phase I clinical trials of an advanced therapy. She handled issues and CAPAs, as well as performing audits both internally and of vendors. During this time she was also responsible for developing quality metrics for management review.
In her most recent position (prior to DHC) of Principal Quality Assurance Associate, she was also responsible for surveillance of regulatory updates and supporting an on-site GCP lab. This included computer systems validation of laboratory equipment and supporting development of new processes in the lab
Dark Horse Consulting Group
Consultant
PsiOxus Therapeutics
Principal Quality Assurance Associate
Senior Quality Assurance Associate
Circassia
Quality Assistant
Document Controller
University of Southampton
BSc. (Hons) in Biochemistry
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