QC Specialist - GMP Compliance

We are currently looking for a QC Specialist - GMP Compliance to lead the management, tracking and internal documentation assessments of Quality investigations. You will join a clinical-stage biotech organisation whose passion is to work together as one team and noticeably making life changing impact.

Job Responsibilities:

• Quality investigational lead role manage QIEs and input for all QC GMP testing activities at CROs.
• Author, investigate, assess and timely closures of Quality investigations related to CRO GMP testing.
• Support review and monitoring of QC finance / budget, contracts (legal), quotes & invoices.
• Use internal procedures, systems, and root cause analyses tools to perform quality event assessments.
• Track all Quality Events (including OOSs, OOTs, deviations, change controls) raised at CROs.
• Oversight of GMP QC testing and related studies / operations at CROs.
• Attend CRO QC meetings and participate in external audits as required.
• Manage and Track KPIs from CROs and laboratory operations, monitoring performance and ensuring systems are compliant.
• Method qualification and validation input & oversight.
• Support optimisation of systems, including those for specification approval, CoA issue, stability testing and analytical trending.
• Support maintenance of CRO document files and QC modules of Product Specification File.
• Understand & support trending of analytical controls and reference standards.
• Understand and support product stability, trending, shelf-life, and specifications.
• Support QC GMP team in study document and data reviews according to internal procedures and maintaining data integrity.
• Any other assigned duties.

Requirements:

• At least 3-5 years working within GMP environment.
• BSc in Biochemistry or Biological Science.
• Proven experience of authoring, assessing (RCA) and reviewing quality investigation within a QMS.
• Management of CRO testing capabilities.
• Understanding of QC batch release and stability testing requirements.
• Knowledge of Analytical method validation for phase appropriate product stages.
• Author and reviewing of QC / analytical study protocols and reports.
• Managed workflows and procedures supporting data integrity for reporting results.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.