Jr Clinical & Safety Compliance Specialist — IBSA Institut Biochimique

Full description

The figure will ensure compliance with standards and quality standards applicable to clinical research activities, supporting the maintenance of the Quality System and compliance activities within the Preclinical & Clinical Research and Safety function.

Mansions

• Ensure compliance with GCP guidelines and applicable regulations, including MDR and ISO for medical devices;

• Participate in maintaining the Quality System for the GCP Compliance area under the Preclinical & Clinical Research and Safety function;

• Plan, review, prepare or support Standard Operating Procedures (SOPs) and Working Instructions (WIs) for Preclinical & Clinical Research and Safety (QMS, CLR, msds, EDC, MED SOPs/WIs);

• Manage deviations/waivers and corrective and preventive actions (CAPA) related to Clinical Research, Data Management & Statistics activities (including Medical Devices) and Quality System;

• Manage IMPs and IMDs regulatory release;

• Participate, as QA, to computerized system validation projects (GCP Compliance area) and periodic revisions;

• Perform internal audits to ensure the quality of the activities of the Preclinical & Clinical Research and Safety (GCP Compliance area);

• Perform GCP audits at clinical centers, according to defined audit plans;

• Conduct qualification and follow-up audits at CRO, Service Provider and other third parties (GCP area) or review external audits;

• Review clinical documentation before finalization, verifying compliance with regulatory requirements and company SOPs;

• Support and train Preclinical & Clinical Research and Safety staff on aspects of GCP Compliance and regulatory requirements through quality oversight activities;

• Supporting preparation for GCP inspections by regulatory authorities (AIFA, EMA, SwissMedic, FDA, MHRA, etc.);

• Perform further related activities, assigned by management.

Profile required

• Degree, preferably in Life Science or related disciplines;

• Good knowledge of English, written and spoken;

• Experience of at least 3 years in a similar role;

• Knowledge of the regulations and standards applicable to clinical research, medical devices and/or pharmaceutical products (e.g. ISO 14155 and ICH E6);

• Experience in Compliance/Quality Assurance activities within clinical trials with medical devices; knowledge of PCMF and food supplements will be a preferential requirement.

Personal skills and skills

• Problem solving;

• Negotiating capacity;

• Good communication skills.