Data Integrity - CSV Consultant AND Computer Systems Validation Consultant - OQSIE

Project 1 : Data Integrity -Computer Systems Validation
Note: items in red are the must have items.
 
 This Data Integrity Quality and Compliance role will take direction from a Team Leader and/or Data Integrity Manager to support and enhance the quality and compliance operations with respect to Data Integrity. This includes assisting with ensuring systems meet data integrity requirements (ALCOA and 21 CFR Part 11).  This role may also assist with the authoring of solution development lifecycle documents (SDLC) including standard operating procedures, user requirements specifications, detailed design and configuration specifications, test plan, test cases, test strategy, change control, and decommissioning plans.  This role is also expected to assist in continuous quality systems improvement for the Quality Compliance department that interfaces between a set of local site combination product manufacturing quality standards.  Role will work on operations support (User Account Reviews, Periodic System Reviews, Change Controls) and projects support for these types of systems:  laboratory, manufacturing, environmental, quality support, configuration management.  
Responsibilities
 
·        Provide technical and compliance expertise to assist with writing of SDLC documentation in accordance with local procedures, templates, regulatory requirements (e.g., 21 CFR Part 11, 211, 820), and Quality System Standards. 
·        Expert experience in CFR 21 Part 11 and data integrity concepts – specific to logical, procedural and technical/engineering controls
·        Assist, as needed, with the development of sound software and lifecycle validation strategies that are balanced with design, quality, and risk that are defensible and supportable by the business and Quality Compliance organization.
·        Provide technical and compliance expertise to support the continuous improvement of Quality Compliance Departmental operating procedures and processes.  
·        Assist in performing change control impact assessments and work with technical subject matter experts (SMEs)
Qualifications
·        Bachelor’s degree in Computer Science, Information Technology or other science-related discipline
·        Proficient in English
·        Must have documented proof – US Persons Status (citizen, green card holder, etc)
·        5+ years of experience in pharma/device or other regulated industry 
 
Project 2: COMPUTER SYSTEM VALIDATION
JOB DESCRIPTION
NOTE: ITEMS IN RED ARE THE MUST HAVE ITEMS.
 
This IT Systems Quality and Compliance role will take direction from a Team Leader to support and enhance the quality and compliance operations posture for an IT department. This includes authoring solution development lifecycle documents (SDLC) including user requirements specifications, detailed design and configuration specifications, test plan, test cases, test strategy, change control, and decommissioning plans.  This role is also expected to assist in continuous quality systems improvement for this local IT department that interfaces between a set of local site pharma/device manufacturing quality standards and a set of global IT quality standards.  Role will work on operations support (User Account Reviews, Periodic System Reviews, Change Controls) and projects support for these types of systems:  laboratory, manufacturing, environmental, quality support, configuration management.  
Responsibilities
• Provide technical and compliance expertise to write SDLC documentation in accordance with local procedures, templates, regulatory requirements (21 CFR Part 11, 211, 820), and IT Security Standards.  Track and execute computer system Periodic Reviews, User Account Reviews, and other computer system compliance processes as assigned.
• Provide technical and compliance expertise to support the continuous improvement of BT Departmental operating procedures and processes.  
• Assist in performing change control impact assessments and work with technical subject matter experts (SMEs
• Represent IT in site level change control meetings



Qualifications:
 
•         Bachelor’s degree in Computer Science, Information Technology or other science-related discipline
•         Proficient in English
•         3+ years of experience in pharma/device or other regulated industry 
•         Excellent knowledge in writing Validation Documents (e.g. Validation Master Plans, Validation Protocols, Associated SOPs, Part 11 Risk Assessments, Verification Plans, Test Scripts).
•         Must have demonstrated capability in completing projects according to prescribed timelines and other requirements in previous project management or business analyst roles.
•         Solid work ethic with a positive attitude; excellent listener, with good verbal and communication skills.
•         Excellent self-management, time management, and problem solving skills; must be able to multi-task / multi-project.
•         Familiarity with lab systems, plant manufacturing systems, Document Management Systems, CAPA processes, Learning Management Systems, highly desirable.
•         Be able to function in multidisciplinary teams, must possess excellent documentation, presentation, training and computer skills.
•         Experience with SDLC and other IT project management methodologies; Agile development is a plus.
Lean Six Sigma certification and/or experience preferred