Descrizione dell'offerta
Founded in 1946, Fidia is an Italian multinational pharmaceutical company, with R&D, manufacturing, marketing and sales capabilities, and an extensive product portfolio, mainly based on Hyaluronic Acid, in strategic therapeutic areas such as Joint Care, Eye Care, Skin Care, Specialty Care, Health&Wellness Care. Headquartered in Abano Terme (PD), Fidia extends its global reach through local partners and distributors in 120+ countries worldwide, as well as with wholly owned subsidiaries.
To strengthen our Corporate Clinical Safety, Pharmacovigilance and R&D Compliance team, we are recruiting a
Corporate R&D Quality & Compliance Expert Main responsibilities
Support the development, maintenance, and revision of the Corporate R&D Quality Management System, including Corporate/Local SOPs and Working Instructions.
Assist in the interpretation of GCP/GVP-related regulations (ICH, EU, FDA, etc.), translating them into company procedures and policies, and preparing the Quality Management Review.
Provide GxP advice in cross-functional teams, supporting risk identification and risk-based Quality Management approaches.
Support planning, conduction, and reporting of vendor audits, maintain Corporate Qualified Vendor Registries, and coordinate third-party audits and regulatory inspections, including inspection readiness and follow‑ups.
Oversee the implementation of CAPA Plans from inspections and audits, manage the Deviation monitoring system, support the performance of Root Cause Analysis, assess CAPAs, and ensure timely remediation of noncompliance.
Assist in staff qualification, training activities, and maintaining relevant training documentation and support Computer System Validation projects within the Corporate R&D Quality Management System.
Requirements
Bachelor's degree in the scientific field (e.g., Pharmacy, CTF, Biology, Biotechnology) and, preferably, Master’s degree.
At least 1 year of experience in Quality management system in R&D/QA GxP, within a pharma industry, CRO or a service provider.
Good knowledge of Clinical and Pharmacovigilance norms/guidelines/regulations.
Fluent knowledge of English language written and spoken (C1 level).
Good proficiency in using the Microsoft Office suite.
Strong accuracy, discipline and cooperation skills.
Our offer
Open ended contract.
Salary between € 29,900 and € 37,360.
Collective Bonus and company Welfare.
In Fidia you will have unlimited access to training and coaching programs aligned with market best practices and opportunities for professional development through participation in internal job posting processes, pension fund with company integration and health fund, merit review and referral programs, company canteen, staff discounts and access to the flu vaccination campaign.
Fidia Farmaceutici promotes parity and inclusion in all its actions.
All people from the status of candidate to that of employee and throughout the duration of their employment relationship are entitled to the same opportunities and protections regardless of gender identity, sexual orientation, ethnicity, migration background, religion, nationality, age.
All company procedures are therefore drafted in compliance with the principles expressed in the previous point; any divergences should be promptly brought to the attention of the People & Culture Department.
#J-18808-Ljbffr
To strengthen our Corporate Clinical Safety, Pharmacovigilance and R&D Compliance team, we are recruiting a
Corporate R&D Quality & Compliance Expert Main responsibilities
Support the development, maintenance, and revision of the Corporate R&D Quality Management System, including Corporate/Local SOPs and Working Instructions.
Assist in the interpretation of GCP/GVP-related regulations (ICH, EU, FDA, etc.), translating them into company procedures and policies, and preparing the Quality Management Review.
Provide GxP advice in cross-functional teams, supporting risk identification and risk-based Quality Management approaches.
Support planning, conduction, and reporting of vendor audits, maintain Corporate Qualified Vendor Registries, and coordinate third-party audits and regulatory inspections, including inspection readiness and follow‑ups.
Oversee the implementation of CAPA Plans from inspections and audits, manage the Deviation monitoring system, support the performance of Root Cause Analysis, assess CAPAs, and ensure timely remediation of noncompliance.
Assist in staff qualification, training activities, and maintaining relevant training documentation and support Computer System Validation projects within the Corporate R&D Quality Management System.
Requirements
Bachelor's degree in the scientific field (e.g., Pharmacy, CTF, Biology, Biotechnology) and, preferably, Master’s degree.
At least 1 year of experience in Quality management system in R&D/QA GxP, within a pharma industry, CRO or a service provider.
Good knowledge of Clinical and Pharmacovigilance norms/guidelines/regulations.
Fluent knowledge of English language written and spoken (C1 level).
Good proficiency in using the Microsoft Office suite.
Strong accuracy, discipline and cooperation skills.
Our offer
Open ended contract.
Salary between € 29,900 and € 37,360.
Collective Bonus and company Welfare.
In Fidia you will have unlimited access to training and coaching programs aligned with market best practices and opportunities for professional development through participation in internal job posting processes, pension fund with company integration and health fund, merit review and referral programs, company canteen, staff discounts and access to the flu vaccination campaign.
Fidia Farmaceutici promotes parity and inclusion in all its actions.
All people from the status of candidate to that of employee and throughout the duration of their employment relationship are entitled to the same opportunities and protections regardless of gender identity, sexual orientation, ethnicity, migration background, religion, nationality, age.
All company procedures are therefore drafted in compliance with the principles expressed in the previous point; any divergences should be promptly brought to the attention of the People & Culture Department.
#J-18808-Ljbffr
Candidatura e Ritorno (in fondo)
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