Are you looking for a New Job or Looking for better opportunities?
We got a New Job Opening for
Full Details :
Company Name : Cognizant
Location : Kolkata, West Bengal
Position : CSV – Computer System Validation
Job Description : Computer System Validation.
? Experience/ exposure to Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.
? Good communication and technical writing skills are a must
? Developing validation documentation for pharmaceutical equipment, facilities and computerized systems used in GLP, GMP and GCP environments.
? Project Deliverables will encompass validation plans, specifications, test protocols and standard operation procedures and systems may include Process Automation, Laboratory Automation, Enterprise IT Applications and Network Infrastructure.
? CSV, GAMP 5 CPFR Part 11, Validation, Worked in V model, SOP & SDLC Lifecycle
? To provide a planned approach for the implementation of the CSV deliverables, migration due diligence, GXP and Non GXP areas
? Provide guidance and leadership regarding Regulatory Compliance and Quality Management requirement.
? Prepare and execute SCA, URS, MVP, VP, RTM, TP, IQ, OQ, PQ, VSR, Traceability Matrix, FRA / FEMA
? Exposure to Regulatory Audits
? The service will benefit if knowledgeable about and capable of advising on product & ingredient regulation within the industry (not mandatory).
? Using previous use cases and best practice counsel on highly regulated environments
? Ensure the CSV artefacts are in line and meets regulatory requirements
? Preferred Experience in Agile Development
? Knowledge on working in Jira / Service Now
LI-EC2
Employee Status : Full Time Employee
Shift : Day Job
Travel : No
Job Posting : Feb 24 2022
About Cognizant
Cognizant (Nasdaq-100: CTSH) is one of the world’s leading professional services companies, transforming clients’ business, operating and technology models for the digital era. Our unique industry-based, consultative approach helps clients envision, build and run more innovative and efficient businesses. Headquartered in the U.S., Cognizant is ranked 185 on the Fortune 500 and is consistently listed among the most admired companies in the world. Learn how Cognizant helps clients lead with digital at www.cognizant.com or follow us @Cognizant.
This post is listed Under Kolkata jobs
Disclaimer : Localpublic.in works to publish latest job info only and is no where responsible for any errors. Users must Research on their own before joining any company