Requirements: English
Company: Infosys
Region: Brussels Metropolitan Area ,
Role: Senior Consultant
Location: Brussels, Belgium
Infosys''s Domain Consulting Group is seeking a Life Sciences Senior Domain Consultant. You will be the leading validation activities for clients and might also be involved handling IT Compliance audits and assurance and supporting external inspections from Regulatory bodies like FDA, MHRA, European Health Commission, etc.
Required Qualifications:
- At least 7 years of Information Technology experience.
- Minimum 3 years experience in operating in a pharmaceutical / life sciences / medical device / health technology company as an IT Quality / GxP compliance manager or systems validation specialist.
- Experience performing in project teams and providing deliverables involving the evaluation of IT quality and GxP issues in an FDA regulated environment.
- Evaluating IT risk issues, including the use of data and technology to provide greater coverage, targeted precision and insight.
- Evaluating IT and business controls, including those relevant to GxP, IT quality and 21 CFR Part 11.
- Understanding of common IT risk domains, including cybersecurity, privacy, disaster recovery, change management and IT operations.
- Understanding of the software development lifecycle, including expected controls in an FDA regulated environment and associated computer systems validation.
- Understanding of Corrective and Preventive Action (CAPA) issues management in an FDA regulated environment.
- Performing assessments to evaluate IT controls, security, SOD, and potential for optimization as well as implementation and/or configuration of ERP products.
- Broad understanding of the system architecture, data flow, and key financial and operational processes within a pharmaceutical, life sciences, CRO, or medical device organization.
- Candidate must be located within commuting distance of Brussels area or be willing to relocate to the area.
- Fluent French/Flemish language skills.
- Experience and desire to work in a management consulting environment that requires regular travel.
Responsibilities:
- Discussing with project stakeholders for validation planning and scheduling, Risk assessment, assessing GAMP category
- Responsible for defining and Authoring validation strategy and validation summary reports for GxP and non-GxP IT systems
- Review & approve CSV deliverables as a Validation specialist i.e. user requirements, system specifications, Risk assessment, Validation plan, Qualification plans, SOPs, IQ/OQ/PQ, Traceability matrix, Design Specs etc.
- Validate IT systems used by our life sciences client
- Define Project Documentation List
- Author Validation Plan, Validation Report, and review other system deliverables such as URS, FS, CS/DS, IQ, OQ, PQ, FRA, Test Strategy Plan / Report
- Ensure data migration is executed in a controlled manner; execute Data Migration Plan / Report
- Support operational activities such as Change Management, Deviation Management, Periodic Reviews, Retirement, Audits / Inspections
- Ensure stage gates are adhered to as per clients project management methodology
- Provide input on project progression / status to the management team on a periodic basis
- Flag issues / concerns / challenges related to system validation and operational activities
Preferred Qualifications:
- Professional compliance certifications like CISA, CRISC, CISSP, ASQ, etc.
- Knowledge of Agile/Scrum as required for Validation (Certifications like PSM, SAFe Scaled Agilist, PMI ACP are an added advantage).
- Planning and Co-ordination skills.
- Good Communication and Analytical skills
About Us
Infosys is a global leader in next-generation digital services and consulting. We enable clients in more than 50 countries to navigate their digital transformation. With over four decades of experience in managing the systems and workings of global enterprises, we expertly steer our clients through their digital journey. We do it by enabling the enterprise with an AI-powered core that helps prioritize the execution of change. We also empower the business with agile digital at scale to deliver unprecedented levels of performance and customer delight. Our always-on learning agenda drives their continuous improvement through building and transferring digital skills, expertise, and ideas from our innovation ecosystem.
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