About Wipro Limited:
Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO) is a leading global information technology, consulting and business process services company. We harness the power of cognitive computing, hyper-automation, robotics, cloud, analytics and emerging technologies to help our clients adapt to the digital world and make them successful.
A company recognized globally for its comprehensive portfolio of services, strong commitment to sustainability and good corporate citizenship, we have over 243,000 dedicated employees serving clients across six continents.
Together, we discover ideas and connect the dots to build a better and a bold new future.
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About Wipro Job Vacancy:
Wipro Kolkata is hiring candidate for Risk Management Specialist from Medical Device Domain only.
Work Location – Kolkata
Qualification – B.E /B. Tech
Experience – 3 Yrs -6 yrs.
** Only Immediate joiners are preferred. Should be open for WFO.
**Interested candidates can send their CVs to Sarita.Biswas@wipro.com
PRINCIPAL RESPONSIBLITIES –
Be responsible for the product safety risk management deliverables and maintenances of Risk Management file during product development and during lifecycle management per ISO 14971 and product specific regulations and standards.
• Ensures product safety risk management deliverables are created, maintained, and stored in the Risk Management file during product development and during lifecycle management of product per ISO 14971 and product specific regulations and standards.
• Monitors and reports on the product safety risk management performance in the field and ensures deliverables are updated as needed.
• Evaluate process and product changes for their impact to the current Risk Management Files.
• Monitor post product data (e.g. Complaints, Corrective and Preventive Actions (CAPA), Non-conformance Reports (NCRs), Customer Feedback information, etc.) for impact to the Risk Management Files
CRITICAL SKILLS REQUIRED –
• Knowledge and understanding of regulations related to risk management and the development of safe hardware and software products including ISO14971, FDA Regulations 21CFR 820, EU MDR, IEC 60601-1, IEC 62304, and IEC 62366-1.
• Risk Analysis Methodology know-how (e.g., FMEA)
• Excellent interpersonal skills and the ability to influence
• Experience in creating risk management deliverables
• Clinical knowledge an advantage
