GCP Auditor Consultant (Italy, freelance)

Design Space InPharmatics LLC; Italia; À distance; EUR 83 000 - 124 000; Temps partiel

Résumé du poste

ProductLife Group (PLG) seeks a freelance, part-time GCP Auditor Consultant based in Italy to plan, conduct, and report audits at clinical sites, hospitals, and eClinical vendors across Europe. The consultant will work independently, travel within Italy, and possess strong knowledge of ICH GCP, EU regulations, and Italian rules.

Italian is mandatory, with English for documentation. Responsibilities include classification of findings, CAPA recommendations, and support during Health Authority

Qualifications

• Fluent in Italian; English proficiency required for documentation and communication.
• Minimum degree in Life Sciences, Pharmacy, or Medicine with CRO/pharma exposure.

Responsabilités

• Plan, conduct, and independently document GCP audits at clinical sites and hospitals.
• Classify findings by risk level and issue CAPA recommendations.
• Support GCP inspections by health authorities and manage audit follow-up.

Connaissances

Italian language fluency

English language proficiency

Formation

Degree in Life Sciences, Pharmacy, or Medicine

Description du poste

DSI encourages scientific and regulatory professionals to contact us regarding opportunities to join our dynamic team of professionals. We are currently looking to add qualified talent to the positions listed below. DSI offers a congenial work environment, the opportunity to work with knowledgeable subject matter experts in multidisciplinary teams, and flexible scheduling.

GCP Auditor Consultant (Italy, freelance)

ProductLife Group (PLG), a leading international pharmaceutical consulting organization, is seeking a freelance, part time GCP Auditor Consultant based in Italy to support client commissioned GCP audits. The consultant will independently plan, conduct, and report audits at clinical sites and hospitals, eClinical system vendors, and clinical laboratories, primarily in Italy, with opportunities across Europe anticipated from Q1 2027. Candidates must meet the auditor requirements of Article 5 of the Italian Ministerial Decree of 15 November 2011.

Role and Responsibilities

• Plan, conduct, and independently document client-commissioned GCP audits, on-site, at:
  • Clinical sites and hospitals (investigator site audits, Phase I Unit audits), vendors providing systems and services supporting clinical trials (e.g., eCRF platforms, IVRS/IWRS providers, CROs, laboratories)
• Classify findings by risk level (critical / major / minor) and issue comprehensive audit reports with recommendations for corrective and preventive actions (CAPA) related to trial conduct and data integrity,
• Advise and support the audited structures in managing findings and deviations and in developing and implementing CAPAs, then validate and follow up to ensure regulatory compliance,
• Support GCP Health Authority inspections (AIFA and other EU authorities) at site or sponsor level, including preparation, facilitation, and follow up of inspection responses,

Qualifications and Education Requirements

• Degree in Life Sciences, Pharmacy, or Medicine,
• At least 5 years of clinical research experience within a CRO, pharmaceutical or biotech,
• Demonstrated experience in GCP Quality Assurance, with the ability to independently plan and conduct audits,
• Strong knowledge of ICH GCP (E6), EU Regulation 536/2014, and applicable Italian regulations,
• Experience managing findings, deviations, and CAPA processes,
• Fluency in both Italian and English (Italian is mandatory),
• Must meet the auditor requirements of Article 5 of the Italian Ministerial Decree of 15 November 2011 (DM 15/11/2011) and be able to provide supporting documentation.

Additional Notes

• This is a freelance, part time, independent consultant role based in Italy. Audits are performed on site, with travel within Italy required and some travel across Europe anticipated from Q1 2027. Consultants are engaged on a project basis and may be assigned to one or multiple concurrent engagements. Hours are not fixed and will fluctuate based on project requirements, milestones, and client needs. Consultants retain full autonomy to accept or decline project engagements at their discretion,
• The responsibilities outlined in this position represent a general summary of the consulting role and are not intended to be all-inclusive. PLG reserves the right to amend this description as client program needs evolve,
• All applications are reviewed by our human hiring team. No automated screening or AI-based filtering is used to evaluate or eliminate candidates. Every candidate receives personal consideration.

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