CGI Technologies and Solutions, Inc. Validation Analyst in Knoxville, Tennessee
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Category: Business Analysis (functional and technical)
City: Knoxville, Tennessee, United States
Position ID: J0321-2620
Employment Type: Student Internship
Meet our professionals
CGI: An employer of choice
CGI Life Science is seeking career driven management validation resources with strong testing and analysis skills to join CGI Account Invest Team. We are experiencing rapid growth and are looking to expand our capabilities based out of our Knoxville, Tennesee Delivery Center
Your future duties and responsibilities:
Validation Resources possess strong analytical skills and detailed understanding of the solution validation processes across regulated and non-regulated systems. They objectively evaluate information gathered from multiple sources, reconcile conflicts, breakdown high level information into details, and abstract up low-level information to a general understanding distinguishing user requests from the underlying needs of the business.
Strong understanding of any of the following : 21 CFR Part 11, 210, 211, 820(Quality System Regulations) , FDA, Risk Assessment, GAMP 5, Gap Analysis, Remediation, Retrospective Validation, Change Control, CAPA.
Required qualifications to be successful in this role:
Experience using any of the following automated testing tools such as HP ALM, UFT, Selenium, and Mercury
What you’ll be doing:
• - Collaborates with clients, subject matter experts, and technical teams to execute the solutions validation deliverables for planning, development, and implementation and testing
• - Contribute to the execution and documentation for deliverables such as Validation Master Plan, CSV Regulatory Risk Assessment, Validation Protocols (IQ, OQ, PQ), URS, FRS, Requirement Traceability Matrix (RTM), and Validation Summary Report.
• - Demonstrates strong analytical skills and detailed understanding of solution validation processes including a thorough understanding of how to interpret customer business needs and translate them into application and operational requirements.
• - Serves as the conduit between the customer community (internal and external customers) and the services teams in which the validation deliverables flow.
• - Exhibits knowledge of emerging industry practices when solving business problems.
- Analytical Thinking
What you can expect from us:
Build your career with us.
It is an extraordinary time to be in business. As digital transformation continues to accelerate, CGI is at the center of this change—supporting our clients’ digital journeys and offering our professionals exciting career opportunities.
At CGI, our success comes from the talent and commitment of our professionals. As one team, we share the challenges and rewards that come from growing our company, which reinforces our culture of ownership. All of our professionals benefit from the value we collectively create.
Be part of building one of the largest independent technology and business services firms in the world.
Learn more about CGI at www.cgi.com .
No unsolicited agency referrals please.
CGI is an equal opportunity employer.
Qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, pregnancy, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity and gender expression, familial status, political affiliation, genetic information, or any other legally protected status or characteristics.
CGI provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job in the U.S., please email the CGI U.S. Employment Compliance mailbox at USEmploymentCompliance@cgi.com . You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned .
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All CGI offers of employment in the U.S. are contingent upon the ability to successfully complete a background investigation. Background investigation components can vary dependent upon specific assignment and/or level of US government security clearance held. CGI will consider for employment qualified applicants with arrests and conviction records in accordance with all local regulations and ordinances.
CGI will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with CGI’s legal duty to furnish information.