IT QA Compliance Manager - Pharmacueticals

Description

Position:Information Technology (IT) Compliance Manager

Position Reports To: Sr. Director Quality Systems and Compliance

Responsibilities:

• Must have proven experience in Part 11 compliance from a Quality prospective
• Act as QA Project Lead for all IT programs from begin to completion
• Conduct in-depth review of IT Change Control and computerized Risk Assessment processes and documentation
• Participate as an audit team member for vendor/suppliers providing computerized support and/or services
• Participate in the creation of computer system design and implementation documents from a Quality view point to ensure Part 11 compliance
• Write and review User Specification Requirements (URS), User Acceptance Testing (UAT), Functional Specification, trace matrices for accuracy and completeness
• Author IT user, system, IQ, OQ and PQ SOPs, protocols, reports and project charters
• Review documents documents related to software application trace matrices architecture for completeness and alignment with execution documents and Part 11
• Interpret ad provide feedback on test scripts, and validation protocols and reports for accuracy and completeness to part 11 requirements

Experience:

• 8-10 years' experience in Quality with a focus on IT Hardware & Software Implementation

• Experience with Livelink, ComplianceWire, ARISg, ComVault, SAS, VM-Ware and Sharepoint a plus
• Strong IT technical background
• Experience authoring SOP's related to IT Change Control & processing
• Strong knowledge of cGMP, GCP and ICH guidelines, Part 11 for US,Canadaand EU market

Education/ Skills/ Training:

• Communication Skills:
• Ability to work with a diverse group of personalities and individuals
• Excellent writing skills
• Strong verbal communication skills
• Other Skills:
• Ability to work independently and multitasking
• Strong attention to detail and accuracy
• Ability to set schedules and meet deadlines
• Computer Skills:
• Knowledge of Software: MSWord, MSExcel, MSPowerpoint, MSOutlook, Adobe Acrobat, and Visio desired
• B.S. or M.S. in a scientific or engineering discipline or equivalent experience

To find out more about Real please visit www.realstaffing.com