GCP Compliance Specialist

3 settimane fa

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 of first and second party audits.
 

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.

  • GCP Compliance Specialist

    4 settimane fa

    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...

  • GCP Compliance Specialist

    3 settimane fa

    Parma, Italia Chiesi A tempo pieno

    About usBased 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...

  • Pharma Digital Compliance Specialist

    7 giorni fa

    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...

  • Product Compliance

    1 giorno 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...

  • Site Quality

    1 mese 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...

  • HSE Training

    1 mese 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...

  • HSE Training

    1 mese 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...

  • Security Specialist

    4 settimane fa

    Parma, Italia Impresa Pizzarotti & C. S.p.A. A tempo pieno

    Impresa Pizzarotti & C. S.p.A. è stata fondata a Parma nel 1910 come ditta individuale da Gino Pizzarotti, trasformata successivamente nel 1945 in società a responsabilità limitata per opera del geom. Pietro Pizzarotti, padre dell’attuale Presidente Cav. Lavoro Paolo Pizzarotti, è diventata nel 1961 Società per azioni con un capitale sociale di 250...

  • Global Privacy

    4 settimane fa

    Parma, Italia Chiesi Farmaceutici A tempo pieno

    Global Privacy & Legal Innovation Specialist Date: Jan 27, 2023 Department: Legal & Corporate Affairs **Job Type**: Direct Employee Team: Legal, Compliance & Internal Audit 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’...

  • Plant HSE Specialist

    1 mese fa

    Parma, Italia Bormioli Pharma A tempo pieno

    The resource will be part of the HSE team of Castelguelfo (PR) Plant and will manage all the following activities related to Prevention, Protection and Safety of the Plant: Support to the Plant Management in Risk identification and assessment Support the Operational Departments in drafting safety procedures Organization and activities of environmental...

  • Plant HSE Specialist

    1 mese fa

    Parma, Italia Bormioli Pharma A tempo pieno

    The resource will be part of the HSE team of Castelguelfo (PR) Plant and will manage all the following activities related to Prevention, Protection and Safety of the Plant: Support to the Plant Management in Risk identification and assessment Support the Operational Departments in drafting safety procedures Organization and activities of...

  • IT Manager

    1 settimana fa

    Parma, Italia Robert Walters A tempo pieno

    Robert Walters ha fornito un livello di retribuzione Questo livello è fornito da Robert Walters. La tua retribuzione effettiva sarà basata sulle tue competenze e la tua esperienza. Rivolgiti al tuo recruiter per saperne di più. Livello retribuzione di base Il nostro cliente è una delle migliori media agency in Italia, famosi per i loro progetti di...

  • IT Manager

    4 giorni fa

    Parma, Italia Robert Walters A tempo pieno

    Robert Walters ha fornito un livello di retribuzioneQuesto livello è fornito da Robert Walters. La tua retribuzione effettiva sarà basata sulle tue competenze e la tua esperienza. Rivolgiti al tuo recruiter per saperne di più. Livello retribuzione di baseIl nostro cliente è una delle migliori media agency in Italia, famosi per i loro progetti di successo...

  • Rare Disease Clinical Project Manager

    4 settimane fa

    Parma, Italia Chiesi A tempo pieno

    About usBased 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...

  • Computerised System Validation Specialist, prov. Parma

    1 settimana fa

    Parma, Italia Massimi Sistemi S.r.l. A tempo pieno

    Computerised System Validation Specialist, prov. Parma (Italy) We are currently recruiting for our internationally renowned client in the Life Sciences sector, seeking three Computerised System Validation specialists. The ideal candidate will have at least two to three years of operational experience in the pharmaceutical and/or biotech industry,...

  • Computerised System Validation Specialist, Prov. Parma

    1 settimana fa

    Parma, Italia Massimi Sistemi S.R.L. A tempo pieno

    Computerised System Validation Specialist, prov. Parma (Italy)We are currently recruiting for our internationally renowned client in the Life Sciences sector, seeking three Computerised System Validation specialists. The ideal candidate will have at least two to three years of operational experience in the pharmaceutical and/or biotech industry, specifically...

  • Computerised System Validation Specialist, prov. Parma

    4 giorni fa

    Parma, Italia Massimi Sistemi S.r.l. A tempo pieno

    Computerised System Validation Specialist, prov. Parma (Italy)We are currently recruiting for our internationally renowned client in the Life Sciences sector, seeking three Computerised System Validation specialists. The ideal candidate will have at least two to three years of operational experience in the pharmaceutical and/or biotech industry, specifically...

  • Pharmacovigilance Specialist

    3 settimane fa

    Parma, Italia Chiesi Group A tempo pieno

    Who we are looking for Main Responsibilities will be responsible for conducting comprehensive reviews of adverse event reports for investigational and post-marketed products, ensuring compliance with regulatory guidelines and completeness of documentation. Assist in developing Safety forms, standard operating procedures, and...

  • Pharmacovigilance Specialist

    1 mese fa

    Parma, Italia Chiesi Group A tempo pieno

    Who we are looking for Main Responsibilities will be responsible for conducting comprehensive reviews of adverse event reports for investigational and post-marketed products, ensuring compliance with regulatory guidelines and completeness of documentation. Assist in developing Safety forms, standard operating procedures, and process...

  • Pharmacovigilance Specialist

    1 mese fa

    Parma, Italia Chiesi Farmaceutici A tempo pieno

    **Date**: 23 Jan 2024 **Department**: Global Pharmacovigilance **Team**: R&D, Pharmacovigilance & Regulatory Affairs **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,...