07 oct
|
Infosys
|
México
Consultant- Computerized System Validation, Life Sciences- Business Consulting
Domain
Consulting
Interest Group
Infy Mexico
Company
Requisition ID
154350BR
Consultant, Business Consulting – Computer System Validation- Life Sciences
We are looking for smart, self-driven, high-energy people with intellectual curiosity and passion for excellence; specifically, we are looking for candidates at Consultant levels who are experienced in IT Computerized System Validation (CSV) within Life Sciences domain.
Responsibilities:
- Create, review, and approve validation deliverables
- Define IT system development processes (build, test, deploy, monitor) following Agile ways of working and ensure followed compliance in each release /Iteration
- Working experience on Agile/JIRA, Confluence, ALM
- Author major project validation deliverables as per client’s standard operating procedures
- Review and approve system lifecycle deliverables generated by project team
- Guide project teams on applicable validation, security, and project management deliverables
- Contribute to internal and external audits, assessments, or inspections
- Escalate critical compliance findings, risks, or issues into appropriate client units
- Prepare management reports regarding compliance operations and progress
Basic Skills & Experience
- Good understanding of key pharmaceutical compliance regulations like 21 CFR Part 11, GxP and GAMP 5.
- Experience creating, reviewing and approving validation deliverables.
- Knowledge of risk management processes.
- Thorough knowledge in compliance and validation concepts.
- Proven ability in supporting multiple projects, responding quickly to changing situations in complex environments.
- Preferable IT background to understand complexities on the program.
- Collaborative attitude.
- Candidates authorized to work for any employer in Mexico without employer-based visa sponsorship are welcome to apply. Infosys is unable to provide immigration sponsorship for this role at thi
📌 Consultant- Computerized System Validation, Life Sciences- Business Consulting (México)
🏢 Infosys
📍 México