029240-Applications Consultant 2 - Validation Consultant
• Participate in validation activities for deployment of new systems, upgrades, and enhancements
• Author typical validation documentation including Plans, requirements, SOPs, IQ/OQ/PQ, trace matrix, test scripts, and summary reports
• Provide guidance and oversight of validation activities for projects involving GxP relevant computer systems
• Work closely with project team members to incorporate appropriate elements of quality and compliance into the system lifecycle
• Provide oversight and guidance of testing activities including assisting with test script development and documenting defects and test results
• Review and approved computer system validation work products, assuring thoroughness of validation planning and making appropriate progress towards timely completion of validation deliverables
• Take ownership for planning and execution of validation activities
• Local travel may be required
• 8+ years experience in Quality and Compliance with substantial hands-on computer system validation experience
• Experience in FDA regulated environment with good understanding of GxP related processes including Risk Based validation
• Experience with Change Control processes
• Experience with FDA and other international regulations (e.g. 21 CFR Part 11, Part 820, Annex 11)
• Knowledge of FDA guidance’s and industry standards (e.g. GAMP)
• Experience with Change Control processes
• Hands on experience in HP Quality Center and QTP
• Strong verbal and written communication skills
• Able to work as a team player, lead a team or accomplish tasks without supervision.
• Ability to work with remote teams and support several changes/projects simultaneously.
Experience with any of the following systems is highly desired:
• Oracle EBS
• Veeva CRM
• Compliance Wire
With more than 190,000 people, Capgemini is present in over 40 countries and celebrates its 50th Anniversary year in 2017.
A global leader in consulting, technology and outsourcing services, the Group reported 2016 global revenues of EUR 12.5 billion (about $13.8 billion USD at 2016 average rate).
Together with its clients, Capgemini creates and delivers business, technology and digital solutions that fit their needs, enabling them to achieve innovation and competitiveness.
A deeply multicultural organization, Capgemini has developed its own way of working, the Collaborative Business ExperienceTM, and draws on Rightshore®, its worldwide delivery model.
Learn more about us at www.capgemini.com.
Capgemini is an Equal Opportunity Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, national origin, gender identity/expression, age, religion, disability, sexual orientation, genetics, veteran status, marital status or any other characteristic protected by law.
This is a general description of the Duties, Responsibilities and Qualifications required for this position. Physical, mental, sensory or environmental demands may be referenced in an attempt to communicate the manner in which this position traditionally is performed.
Whenever necessary to provide individuals with disabilities an equal employment opportunity, Capgemini will consider reasonable accommodations that might involve varying job requirements and/or changing the way this job is performed, provided that such accommodations do not pose an undue hardship.
As part of the Capgemini Technology Services Group, this person will be responsible for the full systems lifecycle from requirements gathering through implementation of data analysis solutions.
This person will work closely with our clients and must demonstrate professional knowledge to ensure that the work products and deliverables are of the highest caliber to ensure client satisfaction.
This person will also apply subject matter expertise to identify, develop, and implement techniques to improve engagement productivity, increase efficiencies, mitigate risks, resolve issues, and optimize cost savings and efficiencies for each client.
Click the following link for more information on your rights as an Applicant: http://www.capgemini.com/resources/equal-employment-opportunity-is-the-law