Computer System Validation CSV
Computer System Validation CSV
Posted on :
29-10-2024
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Job Description
Computer System Validation (CSV)
Location: Fayetteville North Carolina
Interview: PhoneSkype
Duration :12 Months
Bill Rate: $4045/ hr on W2 Only.
Visa: No H1B
Years of Exp:78
Job Description:
Experience with Moda ES (a MUST)
Review of SOPs and other related administrative documents
Batch review and manufacturing processes
Must be familiar with quality reviews
Excellent communication skills significant writing
Moda Engineer (Configuration) and Moda CSV
Primary Responsibilities:
Work in computer system validation projects related to authoring and executing specifications and validation documentation for enterprise computer systems.
Author validation protocols ensuring that the technology solutions being implemented are compliant with all relevant regulations (i.e. 21 CFR Part 11 Annex 11 GxP local and corporate policies).
Review and (remote) execution Computer System Validation protocols to ensure compliance and adherence with corporate guidelines procedures cGMP and ISPE GAMP 5 guidelines and regulations.
Understands how aspects of data integrity security access and safety are addressed through the various protocols.
Write risks assessments according to GMP and 21 CFR Part 11 compliance guidelines. Prepare validation summary reports for executed protocols.
Assist investigate and resolve Deviations CAPA investigations and other potential issues.
Develops validation deliverables such as Validation Plans Requirements Specifications Validation Protocols Traceability Matrices Summary Reports Change Controls.
Available to attend meetings as necessary
Periodic Review activities
Ability to manage three to four active projects
Applications to support
MODA (EM/ES)
SAP ProcessPad ASCTrac LIMS BMRAM
ELN ComplianceWire
Adobe sign
Jira
Education
BS/BA required in a related field.
Location: Fayetteville North Carolina
Interview: PhoneSkype
Duration :12 Months
Bill Rate: $4045/ hr on W2 Only.
Visa: No H1B
Years of Exp:78
Job Description:
Experience with Moda ES (a MUST)
Review of SOPs and other related administrative documents
Batch review and manufacturing processes
Must be familiar with quality reviews
Excellent communication skills significant writing
Moda Engineer (Configuration) and Moda CSV
Primary Responsibilities:
Work in computer system validation projects related to authoring and executing specifications and validation documentation for enterprise computer systems.
Author validation protocols ensuring that the technology solutions being implemented are compliant with all relevant regulations (i.e. 21 CFR Part 11 Annex 11 GxP local and corporate policies).
Review and (remote) execution Computer System Validation protocols to ensure compliance and adherence with corporate guidelines procedures cGMP and ISPE GAMP 5 guidelines and regulations.
Understands how aspects of data integrity security access and safety are addressed through the various protocols.
Write risks assessments according to GMP and 21 CFR Part 11 compliance guidelines. Prepare validation summary reports for executed protocols.
Assist investigate and resolve Deviations CAPA investigations and other potential issues.
Develops validation deliverables such as Validation Plans Requirements Specifications Validation Protocols Traceability Matrices Summary Reports Change Controls.
Available to attend meetings as necessary
Periodic Review activities
Ability to manage three to four active projects
Applications to support
MODA (EM/ES)
SAP ProcessPad ASCTrac LIMS BMRAM
ELN ComplianceWire
Adobe sign
Jira
Education
BS/BA required in a related field.
Employment Type
Full Time
Key Skills
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