Gcp Compliance Specialist

2 mesi fa


Parma, Italia Chiesi Farmaceutici A tempo pieno

**Date**: 15 Apr 2024
**Department**: Global R&D Quality Assurance
**Team**: Quality

**Job Type**: Direct Employee
**Contract Type**: Permanent

**Location**:
Parma, IT

About us

Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas: Discover more here

We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes a transparent and ethical behavior at all levels.

We believe that the success of Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors. Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.

In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.

Chiesi Research & Development

Our R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, chemical manufacturing and controls, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management. Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden) and Toronto (Canada).

Who we are looking for

Purpose

Main Responsibilities
Management of CAPA Plans from GCP audits
Management of the requests for the collection of quality metrics, KPIs supporting Global R&D Departments
Management of Trackwise, Suppliers and Audit workflows
Support the management of external consultants supporting the Auditing & Supplier Qualification Unit.
Finalization of Quality Documents supporting the Auditing & Supplier Qualification Unit.
Write/Review SOPs relating to audit and qualification of clinical service providers
Ensure training on relevant activities and procedures
Ensure good documentation and traceability
Execution of GCP first and second party audits
Finalization and management of the GCP audit reports

Experience Required

At least 3 years’ experience in Pharmaceutical, Consultancy Companies or Contract Research Organization in the Research & Development environment Quality Assurance with robust knowledge of GCP supporting clinical trials and knowledge of compliance.
ISO auditor Certification to be considered an added value

Education

Scientific degree

Languages

Good knowledge of English

Technical Skills
Knowledge of GCP requirements and quality system
Knowledge of the pharmaceutical development process supporting clinical trials
Knowledge of training technique
Knowledge of auditing technique to be considered an added value

Soft Skills
Planning and organizational skills
Strategic thinking
Team working
Quality orientation
Communication skills

What we offer

You would join a dynamic, fast-growing, challenging and friendly environment.
In Chiesi we firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.
We want our people to come to work happy every day, and we know how important it is to find the right work-life balance in order to be able to give our best. That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.

DISCOVER ALL OUR JOB OPPORTUNITIES
Screen readers cannot read the following searchable map.
Follow this link to reach our Job Search page to search for available jobs in a more accessible format.



  • Parma, Italia Chiesi Group A tempo pieno

    Who we are looking for Purpose To verify and ensure the compliance and the correct application of Good Clinical Practices (GCP) being primarily responsible for the management of all the GCP CAPAs, preparation of the quality metrics, KPIs supporting the compliance inside Global R&D Departments, management of Quality Documents and by execution...


  • Parma, Italia Chiesi Group A tempo pieno

    Who we are looking for Purpose To verify and ensure the compliance and the correct application of Good Clinical Practices (GCP) being primarily responsible for the management of all the GCP CAPAs, preparation of the quality metrics, KPIs supporting the compliance inside Global R&D Departments, management of Quality Documents and by...


  • Parma, Italia GSK A tempo pieno

    **Site Name**: Italy - Parma **Posted Date**: May 10 2024 We create a place where people can grow, be their best, be safe, and feel welcome, valued, and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern...


  • Parma, Italia GSK A tempo pieno

    **Site Name**: Italy - Parma **Posted Date**: May 14 2024 We create a place where people can grow, be their best, be safe, and feel welcome, valued, and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern...


  • Parma, Italia 532 GlaxoSmithKline Manufacturing SpA A tempo pieno

    We create a place where people can grow, be their best, be safe, and feel welcome, valued, and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practises; our Performance with Choice programme offers...


  • Parma, Italia 532 GlaxoSmithKline Manufacturing SpA A tempo pieno

    We create a place where people can grow, be their best, be safe, and feel welcome, valued, and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practises; our Performance with Choice programme offers a...


  • Parma, Italia 532 GlaxoSmithKline Manufacturing SpA A tempo pieno

    We create a place where people can grow, be their best, be safe, and feel welcome, valued, and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practises; our Performance with Choice programme offers a...


  • Parma, Italia 532 GlaxoSmithKline Manufacturing SpA A tempo pieno

    We create a place where people can grow, be their best, be safe, and feel welcome, valued, and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practises; our Performance with Choice programme offers...


  • Provincia di Parma, Emilia-Romagna, Italia Gruppo Eurocar Italia A tempo pieno

    Gruppo Eurocar Italia, controllato al 100% da Porsche Holding Salisburgo, è in Italia il più grande gruppo di vendita ed assistenza per i marchi del Gruppo Volkswagen. Con oltre 1.700 collaboratori distribuiti in 44 sedi siamo presenti in Friuli-Venezia Giulia, Lombardia, Veneto, Trentino-Alto Adige, Toscana, Piemonte, Liguria ed Emilia-Romagna dove...

  • Corporate Compliance

    4 giorni fa


    Provincia di Parma, Emilia-Romagna, Italia Maps S.p.A. A tempo pieno

    In Maps Group consideriamo i processi interni e la qualità degli stessi un elemento strategico per competere sul mercato. Per questo Maps Group è un’azienda certificata secondo gli standard ISO 9001 internazionali. Allo scopo di mantenere e monitorare la Compliance aziendale in merito a questi temi per noi importantissimi, siamo alla ricerca di una...


  • Parma, Italia Chiesi Farmaceutici A tempo pieno

    **Date**: 30-Mar-2023 **Department**: Global Clinical Development **Team**: R&D, Pharmacovigilance & Regulatory Affairs **Job Type**: Direct Employee **Contract Type**: Temporary **Location**: Parma, IT About us Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience,...

  • Product Compliance

    3 giorni fa


    Parma, Italia Chiesi Farmaceutici A tempo pieno

    **Data**: 17 mag 2024 **Dipartimento**: Parma Quality Operations **Team**: Industrial Operations & HSE **Tipo Lavoro**: Dipendente **Tipologia Contratto**: Tempo indeterminato **Località**: Parma, IT Chi siamo Con sede a Parma, in Italia, Chiesi è un gruppo farmaceutico e sanitario internazionale focalizzato sulla Ricerca, con oltre 85 anni di...

  • Product Compliance

    4 settimane fa


    Parma, Italia Chiesi Group A tempo pieno

    Chi siamo Con sede a Parma, in Italia, Chiesi è un gruppo farmaceutico e sanitario internazionale focalizzato sulla Ricerca, con oltre 85 anni di esperienza, che opera in 30 paesi con più di 6.000 dipendenti (Gruppo Chiesi). Per realizzare la sua missione di migliorare la qualità della vita delle persone, agendo responsabilmente nei confronti...


  • Parma, Italia Chiesi Farmaceutici A tempo pieno

    **Date**: 30-Mar-2023 **Department**: Corporate R&D Quality Assurance **Team**: Quality **Job Type**: Direct Employee **Contract Type**: Permanent **Location**: Parma, IT About us Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 30 countries with more...

  • Product Compliance

    2 settimane fa


    Parma, Italia Chiesi Group A tempo pieno

    Chi siamo Con sede a Parma, in Italia, Chiesi è un gruppo farmaceutico e sanitario internazionale focalizzato sulla Ricerca, con oltre 85 anni di esperienza, che opera in 30 paesi con più di 6.000 dipendenti (Gruppo Chiesi). Per realizzare la sua missione di migliorare la qualità della vita delle persone, agendo responsabilmente nei confronti...

  • Site Quality

    6 giorni fa


    Parma, Italia Chiesi Farmaceutici A tempo pieno

    **Date**: Jun 1, 2023 **Department**: Parma Quality Operations **Job Type**: Direct Employee **Team**: Quality **Contract Type**: Permanent **Location**: Parma, IT About us Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 30 countries with more than...


  • Parma, Italia E-Work Filiale Di Parma A tempo pieno

    e-work SpA Agenzia per il lavoro cerca, per importante azienda di comunicazione di Parma, un/una  ADMINISTRATION SPECIALIST . La ricorsa svolgerà operazioni contabili e amministrative, legate al controllo di gestione.     Responsabilità: Gestire di emissione e ricezione fatture. Gestire di ricevute. Gestire di pagamenti e incassi. Gestire della...


  • Parma, Italia E-Work A tempo pieno

    e-work SpA Agenzia per il lavoro cerca, per importante azienda di comunicazione di Parma, un/una  ADMINISTRATION SPECIALIST .La ricorsa svolgerà operazioni contabili e amministrative, legate al controllo di gestione.    Responsabilità: Gestire di emissione e ricezione fatture.Gestire di ricevute.Gestire di pagamenti e incassi.Gestire della...

  • Hse Training

    2 mesi fa


    Parma, Italia Chiesi Farmaceutici A tempo pieno

    **Data**: 25 mar 2024 **Dipartimento**: Corporate Health Safety & Environment **Team**: Industrial Operations & HSE **Tipo Lavoro**: Dipendente **Tipologia Contratto**: Tempo indeterminato **Località**: Parma, IT Chi siamo Con sede a Parma, in Italia, Chiesi è un gruppo farmaceutico e sanitario internazionale focalizzato sulla Ricerca, con oltre 85 anni...


  • Parma, Italia Chiesi Farmaceutici A tempo pieno

    **Data**: 1-mar-2023 **Dipartimento**: Plant Operations via S. Leonardo **Team**: Quality **Tipo Lavoro**: Dipendente **Tipologia Contratto**: Tempo indeterminato **Località**: Parma, IT Chi siamo Con sede a Parma, in Italia, Chiesi è un gruppo farmaceutico e sanitario internazionale focalizzato sulla Ricerca, con oltre 85 anni di esperienza, che...