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QA CSV Engineer
Eingestellt von Roc Search Limited
Gesuchte Skills: Support, Engineering, Engineer
Projektbeschreibung
Roc Search is currently recruiting for a QA CSV Engineer to work for a client based in Cork, Ireland.
Responsibilities:
*Develop a process for the validation of computer and automation systems ensuring compliance to required regulatory requirements.
*Coordinates and executes training of required personnel on the computer and automation systems validation procedures and methodology.
* Keeps systems and processes developed for computer and automation systems validation up to date and compliant.
*Gives guidance on all activities related to computer and automation systems validation.
*Support activities include, but are not limited to, SOP creation, documentation review and approval
*Including change controls, assessment plans, risk assessment reports, compliance plans, user requirements, system and user acceptance testing protocols, traceability Matrix, error reports/defect report forms and summary reports
*Compiles and analyses validation data and makes recommendations for changes and/or improvements.
*May also investigate and trouble-shoot problems which occur and determine solutions.
*Maintains all documentation pertaining to computer systems validation.
*Participates on cross-functional project teams with the support of Development, Manufacturing, Engineering, Quality, and other groups.
*As required, prepares summaries of validation testing for regulatory submissions and presents validations to regulatory agencies.
Knowledge, skills and experience:
*Experience in CSV system development life cycle is required.
*Validation experience with ERP, MES, LIMS, and Quality Systems is preferred.
*Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11 is required
*Strong knowledge of system development life cycle is required.
*The ability to travel up to approx. 10% (domestic and international) is required.
Type: Immediate
Duration: 12 Months
Rate: Market Rate
Location: Cork, Ireland
Apply now for immediate consideration.
As a professional company we gladly welcome applications from persons of any age and background and do not intend to discriminate with advert text and terminology.
Responsibilities:
*Develop a process for the validation of computer and automation systems ensuring compliance to required regulatory requirements.
*Coordinates and executes training of required personnel on the computer and automation systems validation procedures and methodology.
* Keeps systems and processes developed for computer and automation systems validation up to date and compliant.
*Gives guidance on all activities related to computer and automation systems validation.
*Support activities include, but are not limited to, SOP creation, documentation review and approval
*Including change controls, assessment plans, risk assessment reports, compliance plans, user requirements, system and user acceptance testing protocols, traceability Matrix, error reports/defect report forms and summary reports
*Compiles and analyses validation data and makes recommendations for changes and/or improvements.
*May also investigate and trouble-shoot problems which occur and determine solutions.
*Maintains all documentation pertaining to computer systems validation.
*Participates on cross-functional project teams with the support of Development, Manufacturing, Engineering, Quality, and other groups.
*As required, prepares summaries of validation testing for regulatory submissions and presents validations to regulatory agencies.
Knowledge, skills and experience:
*Experience in CSV system development life cycle is required.
*Validation experience with ERP, MES, LIMS, and Quality Systems is preferred.
*Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11 is required
*Strong knowledge of system development life cycle is required.
*The ability to travel up to approx. 10% (domestic and international) is required.
Type: Immediate
Duration: 12 Months
Rate: Market Rate
Location: Cork, Ireland
Apply now for immediate consideration.
As a professional company we gladly welcome applications from persons of any age and background and do not intend to discriminate with advert text and terminology.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges