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Gcp Auditor/ Quality Manager

TFS HealthScience is excited to be expanding our HR team and we are looking for an experienced, highly motivated Quality Assurance based in Barcelona.

We are a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. We combine the full-service capabilities and global reach of a large CRO with the flexibility and personal approach only a mid-size CRO can deliver.  

Our cores values of Trust, Quality, Flexibility and Passion are what makes TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organization. Together we make a difference.

The Quality Manager / GCP Auditor is a position in the Quality & Compliance Department. The Quality Assurance Manager is capable of independently conducting all types of GxP audits including system audits according to company policies, SOPs and regulatory requirements. This person has experience in clinical research and quality assurance and is able to provide support and advice throughout this area.

Key responsibilities:

  • Prepare, conduct and follow up on all types of internal and external GxP audits including System, Investigator site, Document, Data Management
  • Assist in preparing investigational sites for regulatory inspections
  • Facilitate customer audits of the company and/or projects
  • Review audit reports for other quality assurance personnel
  • Provide quality assurance advice and support to internal and external clients
  • Participate in internal meetings as required and liaise with other departments as necessary
  • Actively contribute to continuous improvement of the organisation and development of routines to enhance the work at TFS
  • Develop new (and review existing) quality assurance SOPs as required
  • Maintain required knowledge of applicable regulations and company GxP standards and procedures
  • Assist in writing SOPs for other departments
  • Assist with business development of external quality assurance services
  • Accompany Commercial Operations colleagues on customer visits and participate in presentations when required.
  • Act as trainer
  • University/college degree or equivalent industry experience
  • Awareness of global trends, government policies and regulations in the clinical trials area
  • In depth knowledge of GxP regulations and guidance
  • Good computer skills (Microsoft Word and Excel)
  • Ability to work independently and efficiently
  • Good planning, organisation and problem solving abilities
  • Fluent in English, both written and verbal
  • Several years’ experience in clinical research, (e.g. monitoring, data management, drug safety, training, etc.)
  • Three to 10 years’ experience of auditing in two to three GxP areas
  • International travel to audit sites, worldwide
  • Membership of a quality association (e.g. the Research Quality Association)
  • Private Health Insurance
  • Global General Liability Insurance
  • Global Travel Insurance
  • Internet costs are covered by TFS
  • Flexible working schedule

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