Helen Edwards PhD

QA Officer, regenold UK & Ireland

Maidenhead, England, United Kingdom

About

An experienced postgraduate former research scientist with nine years in pharmaceutical small molecule and biologics drug discovery, and recent QA/administrative experience within a CRO. Methodical worker who takes pride in diligent, detail-orientated work. Self-motivated and highly adaptable with an aptitude for mastering new skills and systems. Proven success multi-tasking across projects with pressured timelines. Following redundancy through corporate reorganisation, seeking to apply my skills to a new challenge in the Pharmaceutical/Life Sciences industry. Key Skills: -Strong sense of protocol; accustomed to working in a highly regulated environment -Quality Assurance -Drug discovery and development expertise (immunology, oncology, fibrosis) -Excellent communication and interpersonal skills -Attention to detail -Report writing, technical review, proofreading and editing (QLS Level 4) -Strong organisational skills; project coordination and administration -Problem-solving and process optimisation

Experience

  • QA Officer at regenold UK & Ireland
    Jul 2025 - Present · 1 yr

  • Quality Assurance Administrator at Bionical Emas
    Aug 2024 - Dec 2024 · 5 mos

    • Provided clerical and administrative support for non-compliance management and auditing/inspections: o Tracked deadlines, liaised with QE/CAPA Owners, and collated and circulated reports. o Handled documentation requests, scheduled meetings, tracked findings, responses and CAPA for Client audits & Regulatory Authority inspection; included tracking upcoming audits/inspections, filing documentation and managing vendor/supplier qualification. • CoordinatedQA meetings, including scheduling, agenda / report collation & dissemination, minute taking, action tracking, filing. •Administered the electronic Learning Management System (eLMS), including allocating users, producing compliance reports and providing support to wider staff. • Proofread, edited, and administered controlled documents(policies, standard operating procedures, etc.).

  • CPD - Level 4 diploma Proofreading and Editing at College of Media and Publishing
    Sep 2021 - Mar 2023 · 1 yr 7 mos

  • Teaching Assistant at Alwyn Infant School
    Feb 2020 - Aug 2021 · 1 yr 7 mos

  • Parental Career Break at Self-employed
    Apr 2016 - Jan 2020 · 3 yrs 10 mos