Senior Consultant â Life sciences Domain
Senior Consultant â Life sciences Domain
Posted on :
23-06-2025
Employer Active
1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
23-06-2025
Job Description
Infosys is seeking Life Sciences Domain Consultant. As a commissioning and Qualification consultantyou 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 Health Canada etc.
Required Qualifications:
The job entails sitting as well as working at a computer for extended periods of time. Should be able to communicate by telephone email or face to face.Infosys is seeking Life Sciences Domain Consultant. As a Consultant and Subject Matter Expert 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 Health Canada etc.
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.
Infosys provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy childbirth or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability.
Required Qualifications:
- Candidate must be located within commuting distanceIndianapolis INor be willing to relocate to the area. This position may require travel in the USA.
- Bachelors degree or foreign equivalent required from an accredited institution. Will also consider three years of progressive experience in the specialty in lieu of every year of education.
- At least 4years of Information Technology experience.
- Strong Quality and compliance experience.
- Performing on 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 Corrective and Preventive Action (CAPA) issues management in an FDA regulated environment
- OT System commissioning and Qualification (Radio ligand Therapy or critical dosage forms will be a plus)
- Experience to MES QMS (Track wise).
- PAS/DCS Qualification.
- ISA95 High level of understanding.
- OT Security will be a plus.
- PAS/DCS Integrated with Manufacturing Equipment qualification.
- Stakeholder management and good executor with required communication.
- Experience and desire to work in a management consulting environment that requires regular travel.
- Knowledge of Agile/Scrum as required for Validation.
- Experience and desire to work in a management consulting environment that requires regular travel
- Planning and Co-ordination skills
The job entails sitting as well as working at a computer for extended periods of time. Should be able to communicate by telephone email or face to face.Infosys is seeking Life Sciences Domain Consultant. As a Consultant and Subject Matter Expert 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 Health Canada etc.
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.
Infosys provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy childbirth or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability.
Required Experience:
Senior IC
Employment Type
Full Time
Key Skills
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