GxP Audit Coordinator

1 week ago


UK, UK, United Kingdom Planet Pharma Full time

Role: GxP Audit Coordinator

Location: Remote in the UK

Contract: 6 months contract iniitally with possibility of extension. Full-time role

Company: Global Pharmaceutical Company


Join us in this exciting role working for a successful global biotechnology company. They are looing for a GxP Audit Coordinator. This role is not looking for an auditor but for project managers/administrators who can liaise with their external audit partners and follow up with internal stakeholders.



Responsibilities:

  • Support the audit and inspections department with logistical coordination, documentation management, and operational tasks for both internal and external audits and inspections.
  • Ensure compliance with Good Practice (GxP) guidelines across all operational processes.
  • Work closely with internal and external stakeholders to allocate resources, schedule audits, monitor timelines, create Corrective and Preventive Action (CAPA) Plans, and manage follow-up actions through to completion.
  • Provide daily support to internal teams, ensuring smooth operations and adherence to audit schedules and CAPA plan deadlines.
  • Maintain accurate documentation of audit and inspection activities, and prepare reports that summarize findings and operational insights.
  • Assist with the preparation and logistics for regulatory authority inspections as required.


Job Requirements:

  • Bachelor’s degree in Life Sciences or a related field.
  • At least 3-4 years of experience in a Biotech, Pharmaceutical, or CRO setting with a focus on GxP compliance.
  • Knowledge of GxP areas such as GMP, GDP, GCP, GLP, and familiarity with regulations in the EU, US, and RoW.
  • Good working knowledge of how an audit works operationally.
  • Ability to work independently in a dynamic environment, with the flexibility to adjust priorities as necessary.
  • Strong project management skills and multitasking abilities.
  • Proven track record of effective collaboration with internal and external stakeholders.
  • Excellent interpersonal and communication skills.
  • Proficient in written and spoken English, with strong technical writing abilities.


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