Proactive and motivated person with minimum 3 to 10 + years of experience in Computer System Validation (CSV) in GxP and Non-GXP systems like General Information Systems / Infrastructure Qualification / Laboratory System / SAPS Systems , of which at least 6+ years of exp as Validation Lead / Validation Manager / Qualification Manager role. Experience must include full life cycle validation of GAMP Cat 4 and Cat 5 Systems / IT Infrastructure Qualification.
• Experienced in working directly with US / European clients and their IT Compliance / QA.
• Good understanding of different SDLC methodologies, IT Service Management Processes and LS QMS Processes.
• Ability to strategize, plan and oversee the validation of Computerized Systems.
• Experienced in GXP Risks, 21 CFR 11, and Annex 11 (or ERES) Assessments.
• Highly skilled and experienced in authoring / review of validation documentation such as URS, FRS, and DS, Validation Plan, Training Plan, Issues Log, Design Review, IQ Protocol/Report, OQ Protocol/Report, PQ Protocol/Report, Test Scripts, Traceability Matrix, and Validation Report, etc.
• Experienced in preparing and finalizing test impact assessment, estimates, strategy and plans.
• Expert author or support of validation test scripts (IQ/OQ), support creation of PQ (on business processes).
• Good experience in Change Control, CAPA and Deviation documentation, review and approval.
• Excellent QA Review skills and experienced in guiding and providing feedback to multi-cultural / geographically different teams.
• Good experience in working on automated testing and validation management tools like HP ALM, JIRA, ValGenesis, Document Management Tools, etc.
• Experienced in performing Periodic Reviews Good understanding of GXPs and its requirements.
• Good understanding of global regulations and Health Authorities, Medical Devices Regulatory expectations governing computerized systems. Must be experienced in supporting CSV Audits / Regulatory Inspections.
• Experienced in managing Validation and Testing Teams of at least 10 members. Must be experienced in Validation Estimation, Project Planning, Tracking and Reporting.
• Ability to identify, analyze and mitigate validation project risks.
• Excellent English communication and interpersonal skills.
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 specialize in enterprise-wide software testing including all its processes and tooling (e.g. TMap). You act as a stream lead on complex international engagements and you are proficient in analyzing and assessing commercial benefits. You contribute to multiple winning bids and are a technical lead on a significant bid. You are successful at winning pull-through or add-on business to existing accounts and have strong knowledge of at least two service offers. You are an active coach and mentor who helps in coaching others through the certification process. You actively participate in the ongoing development of certification programs and lead briefings or training sessions.
• Qualification: 12+ years experience, Bachelor’s Degree.
• Certification: Should have SE level 2 and is seeking SE level 3.
• Must have experience in Testing Lifecycle, Testing Expertise, Testing Techniques, Testing Management, Architecture Knowledge, Technical Solution Design and Quality Management.
• Should be proficient in Business Analysis and Business Knowledge.
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.
Visit us at www.capgemini.com. People matter, results count.