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IT Quality Assurance GxP Specialist

IT Quality Assurance GxP Specialist

Assago, IT

Assago, IT

Position Snapshot

Nestlé in Italy, Milan headquarters 
IT Office of the CIO, IT Quality & GxP Pharmaceutical ServicesIT reporting to Senior IT Performance and Pharma Quality Product Group Manager
Permanent contract with competitive base salary 
Full-time work on location with optional remote working
Bachelor's degree in business, computer science, systems analysis, or related studies and experience
At least 3-5 years’ experience in a similar role within engineering or computer system validations, relevant degree e.g. chemistry, significant experience in the application of quality/compliance principals within a pharmaceutical environment
 

Position Summary

Are you ready to join our global IT team for supporting Nestlé Health Science S.A. and Nestlé Institute of Health Sciences to provide GxP phamaceutical services for making their IT a compliant environment ?

In this position you will work with our IT Merger & Acquisition team, project managers and business colleagues, being responsible in the services for GxP system validation, IT infrastructure GxP Domains tasks, inspection and validation of qualification documentation. You will manage an external provider in charge of delivering the services, ensuring the right profiles is provided for projects, managing contracts, and managing relationships between all involved parties. You will ensure adoption and usage of the services, ensuring the service receivers satisfactions

A day in the life of...

  • Introduce your product and services to Business Colleagues and share value of working with you and your 3rd party partners
  • Collaborate with Merger and Acquisition project team to ensure that the validation of GxP systems is in compliance with our quality management system
  • Coordinate all validation activities for GxP systems as directed by the relevant Quality Representative
  • Ensure effective interaction with IT services and providers achieving and maintaining compliance of GxP IT Systems
  • Participate in continuous improvement processes for simplifying validation and manufacturing related processes while also driving improvements in quality and validation effectiveness
  • Take care of Documentation systems, ensure its evoluation and provide the adequate support model
  • Manage all aspects of the Nestlé IT Quality System, from its vision and strategy, to its evolution maintenance and support
  • Manage the outsourced services provided by the external provider for the EDMS system maintenance, evolution, upgrades, ...)
  • Run training sessions on GxP requirements, Nestlé IT GxP Standards, SOPs and Standard routines
     

What will make you successful

  • At least 3-5 years’ experience in a similar role within engineering or computer system validations.
  • Relevant degree e.g. chemistry.
  • Significant experience in the application of quality/compliance principals within a pharmaceutical environment.
  • Knowledge and experience of performing CSV activities for GxP Systems used in Life Science industries
  • Knowledge of software development life cycle methodologies, including waterfall and agile 
  • Knowledge of QMS, Company Systems and Regulatory expectations.
  • Participation in team-based project work with cross-functional team members.
  • Ability to communicate validation concepts/strategies to project teams.
  • Be a self-starter and be adaptable to a fast-paced working environment.
  • Be able to integrate into current groups and interact well with people.
  • Experience with complex IT deployments, utilising multiple test environments
  • Experience with deployments or experience with validation of integrated systems
  • Experience working in a cGMP/FDA/EMA regulated environment.
  • Knowledge of latest regulatory/industry standard approaches to Data Integrity
  • Knowledge of GAMP5 and Full CSV Life-cycle
  • Fluent English
     

More about Nestlé IT

Office of the CIO is providing a range of guidelines, framework, decision rights and oversees IT strategic planning, performance measurement, vendor management, talent and workforce planning, and IT Quality & GxP Pharmaceutical Services. It also includes the responsibility of our transformation towards an IT product-based operating model to deliver strategic value to the organization. We provide IT services to the entire Nestlé Group, the world’s largest food and beverage company with 89.8 billion Swiss Francs in sales in 2017 and 323,000 employees. We continuously improve our products for the workforce, operating in 189 countries by embracing Agile ways of working and evolving to quickly address new requirements.  We design and support our solutions end-to-end.  This means we not only deliver great IT solutions with the best user experience​, we also quickly resolve issues as they arise.  Learn more about the Nestlé Group and reasons to join us on www.nestle.com.

Position Snapshot

Nestlé in Italy, Milan headquarters 
IT Office of the CIO, IT Quality & GxP Pharmaceutical ServicesIT reporting to Senior IT Performance and Pharma Quality Product Group Manager
Permanent contract with competitive base salary 
Full-time work on location with optional remote working
Bachelor's degree in business, computer science, systems analysis, or related studies and experience
At least 3-5 years’ experience in a similar role within engineering or computer system validations, relevant degree e.g. chemistry, significant experience in the application of quality/compliance principals within a pharmaceutical environment
 

Position Summary

Are you ready to join our global IT team for supporting Nestlé Health Science S.A. and Nestlé Institute of Health Sciences to provide GxP phamaceutical services for making their IT a compliant environment ?

In this position you will work with our IT Merger & Acquisition team, project managers and business colleagues, being responsible in the services for GxP system validation, IT infrastructure GxP Domains tasks, inspection and validation of qualification documentation. You will manage an external provider in charge of delivering the services, ensuring the right profiles is provided for projects, managing contracts, and managing relationships between all involved parties. You will ensure adoption and usage of the services, ensuring the service receivers satisfactions

A day in the life of...

  • Introduce your product and services to Business Colleagues and share value of working with you and your 3rd party partners
  • Collaborate with Merger and Acquisition project team to ensure that the validation of GxP systems is in compliance with our quality management system
  • Coordinate all validation activities for GxP systems as directed by the relevant Quality Representative
  • Ensure effective interaction with IT services and providers achieving and maintaining compliance of GxP IT Systems
  • Participate in continuous improvement processes for simplifying validation and manufacturing related processes while also driving improvements in quality and validation effectiveness
  • Take care of Documentation systems, ensure its evoluation and provide the adequate support model
  • Manage all aspects of the Nestlé IT Quality System, from its vision and strategy, to its evolution maintenance and support
  • Manage the outsourced services provided by the external provider for the EDMS system maintenance, evolution, upgrades, ...)
  • Run training sessions on GxP requirements, Nestlé IT GxP Standards, SOPs and Standard routines
     

What will make you successful

  • At least 3-5 years’ experience in a similar role within engineering or computer system validations.
  • Relevant degree e.g. chemistry.
  • Significant experience in the application of quality/compliance principals within a pharmaceutical environment.
  • Knowledge and experience of performing CSV activities for GxP Systems used in Life Science industries
  • Knowledge of software development life cycle methodologies, including waterfall and agile 
  • Knowledge of QMS, Company Systems and Regulatory expectations.
  • Participation in team-based project work with cross-functional team members.
  • Ability to communicate validation concepts/strategies to project teams.
  • Be a self-starter and be adaptable to a fast-paced working environment.
  • Be able to integrate into current groups and interact well with people.
  • Experience with complex IT deployments, utilising multiple test environments
  • Experience with deployments or experience with validation of integrated systems
  • Experience working in a cGMP/FDA/EMA regulated environment.
  • Knowledge of latest regulatory/industry standard approaches to Data Integrity
  • Knowledge of GAMP5 and Full CSV Life-cycle
  • Fluent English
     

More about Nestlé IT

Office of the CIO is providing a range of guidelines, framework, decision rights and oversees IT strategic planning, performance measurement, vendor management, talent and workforce planning, and IT Quality & GxP Pharmaceutical Services. It also includes the responsibility of our transformation towards an IT product-based operating model to deliver strategic value to the organization. We provide IT services to the entire Nestlé Group, the world’s largest food and beverage company with 89.8 billion Swiss Francs in sales in 2017 and 323,000 employees. We continuously improve our products for the workforce, operating in 189 countries by embracing Agile ways of working and evolving to quickly address new requirements.  We design and support our solutions end-to-end.  This means we not only deliver great IT solutions with the best user experience​, we also quickly resolve issues as they arise.  Learn more about the Nestlé Group and reasons to join us on www.nestle.com.

Apply now »