Lyndsey Atkins

CONSULTANT

Bringing seven years of biotech experience focused on quality assurance, computer system validation, and clinical trial oversight.

About Lyndsey

Lyndsey joined Dark Horse in 2021 and brings 7 years of prior experience in small and medium sized biotech focusing on quality assurance alongside computer system validation and implementation.

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 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.

EXAMPLES OF RECENT WORK

  • Selection, Validation and Implementation of a FDA 21 CFR Part11 compliant e-signature system
  • Document Audits of Essential Documents for a number of new Phase I clinical trials including Protocols, Investigator Brochures, ICFs
  • Audit Lead for on-site audits of external vendors including CROs and central laboratories
  • Surveillance and dissemination of COVID-19 based regulatory updates from the FDA, MHRA and EMA

PAST EXPERIENCE

PsiOxus Therapeutics
Principal Quality Assurance Associate
Senior Quality Assurance Associate

Circassia
Quality Assistant
Document Controller

EDUCATION

University of Southampton
BSc (Hons) in Biochemistry

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