Pharma Validation (QCSV) 21 CFR Part 11 Software Engineer (Bridgewater, NJ)

Cedent is a rapidly growing, young and team-oriented organization. Our mission is to provide expertise and counsel rather than resources. We encourage the formation of joint teams with client staff to take a project from inception to implementation. Through this philosophy we provide identifiable business benefits in the most economical manner. Cedent enables business results by being a 'Value Added partner'. It offers integrated portfolio of services to its clients in the areas of Consulting, System Integration for key-industry verticals. Our resources bring their unique perspectives and insight based on their individual experiences, which leads to breakthrough outcomes for our clients. Our people make the difference by consistently delivering outstanding value to our customers.

Position:

• Be responsible for reviewing and approving validation deliverable of GxP regulated computerized systems to ensure full compliance with Health Authority regulatory requirements and adherence to company policies and procedures by supporting computer validation projects and base business support teams.
• Support internal and external Health Authority regulatory audits.
• Be responsible for the approval of SDLC validation documentation deliverables including the approval to release system implementation and/or changes for production use.
• Be responsible for reviewing and approving validation deliverables of GxP regulated computerized systems to ensure full compliance with Health Authority regulatory requirements and adherence to company policies and procedures by supporting computer validation projects and base business support teams.
• Support internal and external Health Authority regulatory audits.
• Be responsible for the approval of SDLC validation documentation deliverable s including the approval to release system implementation and/or changes for production use including 21 CFR part 11
• Be responsible for providing CSV guidance and support to project and/or base business support teams in the resolution of validation documentation corrections and/or test defects
• Perform pre and post review and approval of validation test scripts including test defects Review/approval of validation documentation deliverables such as but not limited to Compliance Plans, User Requirements, System Tests, User Acceptance Tests, Traceability Matrix, and the Compliance Report including final release and approval for production use
• Ensure a high degree of Inspection Readiness for Systems in CSV portfolio with the purpose of minimizing the risk of inspection observations to Business systems/infrastructure within CSV responsibility
• Act as backup project management staff as needed
• Ensure a high degree of Inspection Readiness for Systems in CSV portfolio with the purpose of minimizing the risk of inspection observations to Business systems/infrastructure within CSV responsibility
• Participate in audits, approves audit non-conformity action plans
• Demonstrate an understanding of many relevant Quality and Compliance principles and their applications
• Work with the CSV Manager in developing, monitoring and managing project costs, schedules, resources and quality
• Lead and mentor a team of internal and external resources through the system lifecycle and utilizes expert knowledge regarding risk management practices.
• Assist or drive status meetings to communicate and address project risks or issues
• Work collaboratively with project teams to keep them informed of project status, including any barriers
• Build and maintains trusting, collaborative relationships and partnerships with internal and external stakeholders, which help, accomplish key business objectives, and helps others to do the same.
• Define internal standards to move the organization toward a more positive risk management posture by utilizing extensive knowledge of current and emerging best practices in risk management
• Proactively monitor systems and processes to ensure compliance with standard operating procedures, audit compliance and industry best practices
• Provide an environment which encourages the company's credo and diversity of opinions and thoughts
• Ensure timely completion of assigned training and expense reporting
• Develop and maintain an effective working partnership with senior management.

You Will Enjoy:

• An opportunity to be a part of a great culture, an awesome team, a challenging work environment, and some fun along the way!
• Apply today to learn more and be part of our Growth story.

All applications will be kept strictly confidential and once shortlisted, our team will be in touch with you for further discussions.

Department: Preferred Vendors
This is a non-management position
This is a contract position