Computer System Validation (CSV)

Computer System Validation (CSV)

Location: Fayetteville, North Carolina

Interview: Phone Skype

Duration :12 Month's

Bill Rate: $40-45/ hr on W2 Only.

Visa: No H1B

Years of Exp:7-8

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.