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Process Quality Manager: ITIL, CSV, GxP, GAMP, Validation, IGM
Eingestellt von Sentinel IT LLP
Gesuchte Skills: Support, Engineering
Projektbeschreibung
Process Quality Manager: ITIL, CSV, GxP, GAMP, Validation, IGM
Job Purpose:
To support QA eCompliance with project deliverables as well as typical day to day operational tasks related to data integrity and the related regulatory requirements.
*The key project that this person will support is to provide QA eCompliance oversight as we migrate data and computer systems to other companies that have purchased them along with their associated Business Processes. In addition to this, the transitional situation requires temporary QA oversight as continue to operate the systems as well.
In addition, this person will also support other activities:
*To provide QA support for GxP impact computer system implementation projects. This means ensuring that projects, systems, and processes, meet the requirements of the client Quality Manual.
* To provide excellent QA Operational support to IT departments. This includes assistance with GxP decision making, change control review and approval, SOP review and approval, and review/approval of other GxP related deliverables as needed.
*As the client continues to centralize its computer systems and services, the person in this role will assist with the development and implementation of typical CSV related SOPs and WIs.
*To help drive Quality into IT business processes wherever possible.
*To assist with the review and comment of existing IT CSV-related templates
*To assist with any other typical QA eCompliance responsibilities as required.
Education:
B.S. in Computer Science, Engineering, or other similar scientific degree area
Experience:
It is anticipated this person would have signature authority so they must have at least 7 years in a GxP environment with a thorough understanding of:
*Computer Validation
*Validation of cloud solutions a plus
*21CFR, Part 11
*EU Annex 11
*Typical IT processes
*Current trends in industry related to data integrity
*GAMP5 and its full life cycle
*Project management
*SAP At least 5 successful years working in a QA role in a GxP environment
Job Purpose:
To support QA eCompliance with project deliverables as well as typical day to day operational tasks related to data integrity and the related regulatory requirements.
*The key project that this person will support is to provide QA eCompliance oversight as we migrate data and computer systems to other companies that have purchased them along with their associated Business Processes. In addition to this, the transitional situation requires temporary QA oversight as continue to operate the systems as well.
In addition, this person will also support other activities:
*To provide QA support for GxP impact computer system implementation projects. This means ensuring that projects, systems, and processes, meet the requirements of the client Quality Manual.
* To provide excellent QA Operational support to IT departments. This includes assistance with GxP decision making, change control review and approval, SOP review and approval, and review/approval of other GxP related deliverables as needed.
*As the client continues to centralize its computer systems and services, the person in this role will assist with the development and implementation of typical CSV related SOPs and WIs.
*To help drive Quality into IT business processes wherever possible.
*To assist with the review and comment of existing IT CSV-related templates
*To assist with any other typical QA eCompliance responsibilities as required.
Education:
B.S. in Computer Science, Engineering, or other similar scientific degree area
Experience:
It is anticipated this person would have signature authority so they must have at least 7 years in a GxP environment with a thorough understanding of:
*Computer Validation
*Validation of cloud solutions a plus
*21CFR, Part 11
*EU Annex 11
*Typical IT processes
*Current trends in industry related to data integrity
*GAMP5 and its full life cycle
*Project management
*SAP At least 5 successful years working in a QA role in a GxP environment
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges