Quality Consultant / Validation Engineer (GxP, 21 CFR Part 11 & GAMP)

Location: Durham, NC
Date Posted: 03-06-2018
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Job role: Real World Technology Solutions – IT Quality Consultant
 
Location: Durham, NC
Duration: 6 months+
 
Direct Client
 
JOB DESCRIPTION:
The RWTS Quality Consultant will participate in the oversight of quality programs and deliverables to ensure Real World Technology Solutions (RWTS) work products meet customer expectations and are in compliance with internal procedures and global regulatory requirements. Through consulting and quality reviews of our Systems Development Lifecycle (SDLC) processes, Standard Operating Procedures (SOPs) and resultant deliverables, the IT Quality Consultant will be responsible for providing software quality assurance and excellence for their assigned RWTS innovative technology platforms and solutions.
 
RESPONSIBILITIES:
• Provide subject matter expertise to assigned RWTS delivery teams on Quality, SDLC, and Computer System Validation (CSV) to ensure delivery excellence and maintain compliance with the relevant regulations and global industry standards.
• Review, provide feedback for improvement, and approve Computer System Validation (CSV) deliverables and other quality-related documentation.
• Oversee the tracking of assigned product releases/projects with respect to quality and validation milestones, deliverables and the quality of demonstrated results.
• Participate in or lead Product Quality Reviews on applicable deliverables, delivery practices, key performance indicators & trends by applying solid knowledge of SDLC, SOPs and global regulations.
• Ensure any findings that result from Product Quality Reviews are logged, analyzed and any resulting corrective or preventative actions (CAPAs) are assigned and tracked to completion.
• Provide guidance to RWTS product teams on interpretation and application of procedures applicable to the implementation and operation of IT systems.
• Identify and suggest improvements to the Delivery Assurance related processes and systems.
• Provide regulatory and software quality knowledge and expertise to support high quality application development and deployment while embracing a risk-based approach.
• Provide oversight of risk assessments related to IT systems and platforms.
• Support the RWTS Quality Management team, Global Quality Assurance and Systems Compliance Office (SCO) functions in support of both internal and external audits.
• Track the effectiveness of CAPAs developed by RWTS product teams and ensure the adequate & timely implementation of CAPA commitments.
• Monitor new and emerging regulatory requirements and good practice guidance for GxP computerized system, IT controls and compliance.
 
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:
• At a minimum, Bachelor degree in Business, Computer Science, or engineering related field.
• Minimum 5-8 years of related experience, incl. 5+ years in a regulated/semi-regulated environment.
• Working knowledge of software development/delivery methodologies and regulatory expectations (e.g. GxP, 21 CFR Part 11, EU Annex 11, ICH, ISO, CMMI, etc.) will be a distinct advantage for this role.
• Detail-oriented with strong organizational skills and high quality standards
• Outstanding written communication skills with experience in authoring both internal and externally facing quality related documents
• Team player with excellent interpersonal and communication skills, and experience working with teams in a coaching capacity
• Ability to integrate and apply feedback in a professional manner
• Experience in computerized system lifecycle management and the application of industry best practices.
• Experience with conducting risk assessment and knowledge of current industry good practice for risk assessment methodologies and tools, e.g., GAMP-5, NIST, ICH
• Experience with application of CAPA methodology including structured approach for failure investigation and identification of root cause.
• Experience in participating in regulatory inspections, presenting/defending IT functions in audits or regulatory inspections will be an advantage.
 
Saravanan
 
Phone: 248-415-4549
Fax: 248-603-2599
saravanan@technosoftcorp.com
 


At least a bachelor’s degree in Computer Science, Engineering or related field or an equivalent in education is required for this position.
We are an Equal Opportunity Employer.
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