Data Integrity Compliance Specialist

7 giorni fa


Monza, Italia Thermo Fisher Scientific A tempo pieno

**Role Summary**
In this role you will ensure the adoption of Data Integrity principles and guidelines and promote a culture of continuous improvement.
As Data Integrity Compliance Specialist you will act as the SME during regulatory audits for Data Integrity and customer audits to answer questions and demonstrate to auditors that necessary controls and required competencies are in place.
In this position will closely interact with experienced personnel from operations and/or computer system operations and you will play a key role in supporting the site's growth.
**Main Activities**
- Member of the Data Integrity Governance Team meetings.
- Assess and review all new equipment and instrumentation is assessed appropriately and validated for its intended use and existence, usage, and review of audit trails and 21CFR Part 11 and Annex 11 regulations.
- Executes assessments and status updates to aid Data Integrity Governance team's actions to maintain and proactively improve data integrity.
- Support the Governance Team deliverables and requests.
- Communicates/escalates actions, compliance gaps, and commitments to respective areas, including the Data Integrity & Quality Risk Manager;
- Performs risk assessments to determine high risk equipment and audit trails and take appropriate action to bring into compliance.
- Assist in sourcing, assessing, and recommending instrumentation/equipment for purchase.
- Provides periodic training to all operations to ensure awareness and compliance with data integrity for both paper and electronic records, including inspector interaction and good documentation practices.
- Review and support execution of Change Controls for instrumentation/equipment new implementation and upgrade to cover DI matters.
- Facilitate discussion with vendors and relevant functions about software capabilities in regards to 21CFR Part 11 compliance.
- Execute DI Oversight into the GxP relevant are, it includes Quality, Manufacturing, QC areas;
- Support the Data Integrity & Quality Risk Manager to coordinate the DI Governance team in setting priorities and project assignments;
- Assesses/executes technical responses to questions/issues raised by regulatory agencies and customers;
- Collaborates on projects to meet customer, business, and regulatory requirements for Data Integrity matters.
**REQUIREMENTS**
**Education**
- Bachelor's Degree in Science, Engineering, or related fields
**Technical Skills**
- Solid knowledge of current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (cGDP).
- Experience 21CFR Part 11/Annex11 instrumentation compliance as well as writing and reviewing investigations within TrackWise.
- Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).
**Professional Background**
- Must have at least 3 years experience in a regulated industry including data integrity related to quality control data from lab systems and manufacturing Systems, knowledge of laboratory instrumentation and/or operations equipment and associated computer systems and TrackWise.
- Project Management, Supervision or Management experience are preferred.
**Languages**
- English, Italian (fluent)
**Personality Traits**
- Accountability and proactivity
- Team work player
- Listening, negotiation and communication skills
- Pragmatic and oriented to results achievement



  • Monza, Italia Thermo Fisher Scientific A tempo pieno

    Joining the Quality Function, you will coordinate and facilitate cross-functional groups within Quality Operations on Data Integrity topicsThis position will be responsible for:- Ensuring operations operates under applicable regulatory policies in respect to data integrity/guidelines as well as striving for continuous improvement;The position represents the...

  • Csv Specialist

    2 settimane fa


    Monza, Italia Thermo Fisher Scientific A tempo pieno

    CSV Specialist (Engineer II, Validation) Il CSV Specialist sarà introdotto in un team che collabora con tutte le iniziative più importanti aziendali sul fronte della digitalizzazione, dell’automazione dei processi e del Pharma 4.0. Oltre che dell'esecuzione delle attività di Computer System Validation, assicurando che i sistemi siano in compliance con...

  • Csv Specialist

    1 settimana fa


    Monza, Italia Thermo Fisher Scientific A tempo pieno

    CSV Specialist (Engineer II, Validation)Il CSV Specialist sarà introdotto in un team che collabora con tutte le iniziative più importanti aziendali sul fronte della digitalizzazione, dell'automazione dei processi e del Pharma 4.0.Oltre che dell'esecuzione delle attività di Computer System Validation, assicurando che i sistemi siano in compliance con...


  • Monza, Italia Thermo Fisher Scientific A tempo pieno

    Lo stabilimento produttivo di Monza è un centro di eccellenza globale per quanto riguarda le produzioni di farmaci sterili conto terzi. Entrerai a far parte di un team di oltre 1900 colleghi in un ambiente giovane, dinamico e fortemente orientato all'obiettivo. Con un fatturato di oltre 35 miliardi di dollari e i più grandi investimenti in R&D del settore,...

  • Csv Specialist

    6 giorni fa


    Monza, Italia Thermo Fisher Scientific A tempo pieno

    Il CSV Specialist sarà introdotto in un team che collabora con tutte le iniziative più importanti aziendali sul fronte della digitalizzazione, dell'automazione dei processi e del Pharma 4.0.Oltre che dell'esecuzione delle attività di Computer System Validation, assicurando che i sistemi siano in compliance con quanto previsto dalle normative vigenti...

  • Csv Specialist

    6 giorni fa


    Monza, Italia Thermo Fisher Scientific A tempo pieno

    Il CSV Specialist sarà introdotto in un team che collabora con tutte le iniziative più importanti aziendali sul fronte della digitalizzazione, dell'automazione dei processi e del Pharma 4.0.Oltre che dell'esecuzione delle attività di Computer System Validation, assicurando che i sistemi siano in compliance con quanto previsto dalle normative vigenti...

  • Csv Specialist

    7 giorni fa


    Monza, Italia Thermo Fisher Scientific A tempo pieno

    Il CSV Specialist sarà introdotto in un team che collabora con tutte le iniziative più importanti aziendali sul fronte della digitalizzazione, dell'automazione dei processi e del Pharma 4.0.Oltre che dell'esecuzione delle attività di Computer System Validation, assicurando che i sistemi siano in compliance con quanto previsto dalle normative vigenti...


  • Monza, Italia Thermo Fisher Scientific A tempo pieno

    Lo stabilimento produttivo di Monza è un centro di eccellenza globale per quanto riguarda le produzioni di farmaci sterili conto terzi.Entrerai a far parte di un team di oltre 1900 colleghi in un ambiente giovane, dinamico e fortemente orientato all'obiettivo.Con un fatturato di oltre 35 miliardi di dollari e i più grandi investimenti in R&D del settore,...


  • Monza, Provincia di Monza e Brianza, Italia JOBONAIR A tempo pieno

    Il nostro cliente è un’importante societ italiana licenziataria di prestigiosi brand cosmetici (area beauty, perfumes e make-up). Nell’ambito del potenziamento dell’organico, stiamo stati incaricati di ricercare un/una:COMPLIANCE &, SUSTAINABILITY SPECIALIST Responsabilit : La risorsa selezionata dovr occuparsi delle seguenti attivit :? Gestione della...


  • Monza, Italia Thermo Fisher Scientific A tempo pieno

    As part of the team at Thermo Fisher Scientific, we do meaningful work, that makes a positive impact on a global scale! Join our 120,000 colleagues who bring our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. You’ll find the resources here to achieve your career goals and enable the future of...


  • Monza, Italia Thermo Fisher Scientific A tempo pieno

    As part of the team at Thermo Fisher Scientific, we do meaningful work, that makes a positive impact on a global scale!Join our 120,000 colleagues who bring our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer.You'll find the resources here to achieve your career goals and enable the future of scientific...


  • Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    Requirements:Education: A degree in Cell and Tissue Culture, Pharmacy, Chemistry, Biology, or a related scientific field, or equivalent experience in the same domains.Knowledge: In-depth knowledge of pharmaceutical production and quality control.Regulatory Compliance: Familiarity with Good Manufacturing Practices (GMP) and FDA regulations.Language Skills:...


  • Monza, Italia Docebo A tempo pieno

    Security Compliance Specialist (Cloud & SaaS) Company: DoceboDocebo's learning platform is more than LMS.Drive engagement, productivity, and connections with your customers, partners, and employees.Hey you!Want to work for one of the fastest growing SaaS companies in the world?We're building the next generation of learning software that companies like AWS,...


  • Monza, Italia Thermo Fisher Scientific A tempo pieno

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office At Thermo Fisher Scientific, we are on a mission to enable our customers to make the world healthier, cleaner, and safer. With over $35 billion in revenues and the largest investment in research and development in the industry, we are a world-class organization that values...


  • Monza, Italia Thermo Fisher Scientific A tempo pieno

    **Main responsibilities of Equipment Qualification Compliance Specialist**: - Collaborate with Technical Services to ensure that equipment validation and calibration activities meets cGMP and Corporate Standards over the life cycle. Ensure that any planned changes to the facilities, equipment and utilities, which may affect the quality of the product, are...


  • Monza, Italia Thermo Fisher Scientific A tempo pieno

    **Work Schedule**Standard (Mon-Fri)**Environmental Conditions**OfficeAt Thermo Fisher Scientific, we are on a mission to enable our customers to make the world healthier, cleaner, and safer.With over $35 billion in revenues and the largest investment in research and development in the industry, we are a world-class organization that values performance,...


  • Monza, Italia Thermo Fisher Scientific A tempo pieno

    **Main responsibilities of Equipment Qualification Compliance Specialist**:- Collaborate with Technical Services to ensure that equipment validation and calibration activities meets cGMP and Corporate Standards over the life cycle.Ensure that any planned changes to the facilities, equipment and utilities, which may affect the quality of the product, are...


  • Monza, Italia Adidas A tempo pieno

    Customs Compliance Specialist - Campus South Mantova adidas and KuehneNagel have started a strategic partnership for a highly automated, omni-channel dedicated fulfilment centre in Mantova. Launched in 2024, the Fulfilment Center supports adidas stores, retail shops, wholesalers, and e-commerce customers in 19 countries throughout Southern and Eastern...


  • monza, Italia adidas A tempo pieno

    Customs Compliance Specialist - Campus South Mantova adidas and Kuehne+Nagel have started a strategic partnership for a highly automated, omni-channel dedicated fulfilment centre in Mantova. Launched in 2024, the Fulfilment Center supports adidas stores, retail shops, wholesalers, and e-commerce customers in 19 countries throughout Southern and Eastern...


  • Monza, Italia adidas A tempo pieno

    Customs Compliance Specialist - Campus South Mantovaadidas and Kuehne+Nagel have started a strategic partnership for a highly automated, omni-channel dedicated fulfilment centre in Mantova.Launched in 2024, the Fulfilment Center supports adidas stores, retail shops, wholesalers, and e-commerce customers in 19 countries throughout Southern and Eastern...