GCP auditor

Excelya>Full-time>GCP auditor

Job description

Founded in 2014, Excelya is a “people centered” contract research organization (CRO).

We offer a personal and authentic experience within an ambitious young healthcare company on its way to becoming the leader in clinical research in Europe with our 800 Excelyates. Our unique one-stop provider service model – leveraging a full-service, functional service provider and consultancy – allows our Excelyates to evolve across a wide range of projects. Working with leading experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.

For our team members, excelling with care means enjoying a challenging professional environment that encourages personal, intellectual and operational participation so that together we can be the best in our field. We are committed to empowering each Excelyate to express their natural talents, develop their full potential and invest in our unique project.

 

The activities are the following ones:

GCP Audits preparation, conduct, reporting

  • Prepare, conduct, report GCP Audits (ie., Investigator site audit, Trial Master Files audits, CRO or Vendors qualification/follow-up audits, System audits)
  • Analyse and monitor the key performance indicators of quality audits and share the analysis with the Quality Management System (QMS) team and any other relevant business

GCP Audit Responses Follow-up

  • Advise and support the audited structures (e.g., investigator site, CROs or vendors, study team) in the development and implementation of corrective and preventive actions (CAPAs) to ensure compliance with regulatory requirements and internal procedures.
  • Approve corrective and preventive actions (CAPA) related to audits and if applicable, follow up until the audit closure

GCP Inspection

  • May participate in the preparation of inspections at site or sponsor level
  • May participate during the inspection as a note taker and help the staff in the response to inspectors
  • May Participate in the development and follow-up of the inspection responses

Audit Referent

  • May participate in the development of the audit programme for the molecule (s) under his or her responsibilities
  • Interacts with the QMS Project Team Member
  • Participate in the inspection strategy preparation for the molecule (s) under his or her responsibilities

Outsourcing

  • Participate in the outsourcing of GCP Audits by drafting the specifications, review of Requests for proposal, subcontractor selection, planning the activities of the subcontractor

According to the competencies of the selected candidate the perimeter of the audits can be extended to other perimeters (e.g. GVP).

Profile:

  • Pharmacist (Pharm D), PHD, or Master of science and specific Quality Assurance training. MD a plus.
  • Minimum of 7-10 years experience in a quality assurance or related role including experience on GCP audit conduct
  • Knowledge of applicable regulations to GCP perimeter.
  • Knowledge of applicable regulations to GVP and previous experience on GVP audits will be a plus.
  • Previous experience within pharmaceutical companies and/or Competent Authorities
  • Language: English. Other speaking language is a plus.
  • Proactive to predict issues and solve problems,
  • Ability to establish excellent working relationships
  • Excellent planning and prioritization skills.
  • Strong capacities to work transversally in an international environment

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