Minimum 6+ years of pharmaceutical GxP system validation experience
Leads and performs risk-based validation of GxP systems, develops validation documents using defined CSV process, and communicates project progress throughout the system lifecycle.
Validates system implementations, system upgrades and creates system documentation in accordance with computerized system validation plan and protocols. Deliverables will include Validation Plan, User and Functional Requirements, Requirements Traceability Matrix (RTM), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Validation Summary report.
Facilitates verification and validation activities such as User Acceptance Testing (UAT), test execution, documentation review, and approval. Extensive experience with Infrastructure Qualification is required. Experience with systems like Data Lake, ServiceNow, JDE and Veeva Systems like MedComms, RIM, eTMF and VeevaDocs will be considered a plus.
Responsible and accountable for the development and delivery of a complete validation package: User Requirements Specification (URS), Validation Plan (VP), Installation/Operational/Performance Qualification Protocol (xQP), Installation Qualification (IQ), Functional Requirements Specification (FRS), Operational Qualification(OQ), Performance Qualification (PQ), Traceability Matrix (TM), Validation Summary Report (VSR), Configurations Specification (CS), Administration and User SOPs, Work Instruction (WIs), or Forms and executing these protocols, if needed
Leads and supports CSV projects and related activities for IT supported systems. This involves understanding the business, determining business and system requirements, project planning, timeline, and collaborating with project team members in the development and delivery of validation deliverables including working with business users on developing test cases, performing dry-run, and updating test scripts.
Oversee and take part in the formal test execution of IQ, OQ and PQ to ensure the testing was performed appropriately and the test results are compiled in a timely manner.
Work collaboratively across functions with Quality, IT, Business, and Vendors to plan, coordinate and execute computer system validation activities, and obtain fully approved documents.
Review and/or approve validation documents and related deliverables, such as Configurations Specification (CS), executed test scripts, and system-specific Admin and User SOPs.
Work closely with IT, QA, or Vendor to create Development, Test, Production environments at the right timing to test and implement a new GxP system into production use that meet the 21 CFR Part 11 requirements.
Drives and coordinates system related Change Requests and Deviations / Non-Conformance, in accordance to governing GxP procedures.
Candidates should be flexible / willing to work across this delivery landscape which includes and not limited to Agile Applications Development, Support and Deployment.
Applicants for employment in the US must have valid work authorization that does not now and/or will not in the future require sponsorship of a visa for employment authorization in the US by Capgemini.
Test Consultants are concerned with the independent verification and validation of the products produced by the development process. Testing is carried out in each phase: the requirements are tested by an acceptance test, the system design (analysis and design) by a system and integration test, and the programs by a program and module test.
Required Skills and Experience:
You design and develop more complex tests and non-functional tests. You perform many of the roles required of a software testing project, through which you acquire a full testing lifecycle experience. Typically you perform these roles as a senior member in a wider team. You act as a stream leader with technical delivery ownership within a limited number of technology areas. You contribute to bid or client proposals based on your technological expertise. You have delivery ownership and guide individuals and groups towards desired outcomes. You also actively participate in at least one community.
• Certification: Should have SE Level 1 and seeking level 2, 7-10 years (3 years min relevant experience in the role) experience, Bachelor's degree
• Should be proficient in Business Analysis, Business Knowledge, Testing Lifecycle, Testing Expertise, Testing Techniques, Testing Management, Architecture Knowledge, Technical Solution Design and Quality Management.
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.
Click the following link for more information on your rights as an Applicant – http://www.capgemini.com/resources/equal-employment-opportunity-is-the-law
Capgemini is a global leader in consulting, digital transformation, technology and engineering services. The Group is at the forefront of innovation to address the entire breadth of clients’ opportunities in the evolving world of cloud, digital and platforms. Building on its strong 50-year+ heritage and deep industry-specific expertise, Capgemini enables organizations to realize their business ambitions through an array of services from strategy to operations. Capgemini is driven by the conviction that the business value of technology comes from and through people. Today, it is a multicultural company of 270,000 team members in almost 50 countries. With Altran, the Group reported 2019 combined revenues of €17billion.
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