Computer System Validation Consultant Job Vacancy in InspireXT Consulting Pune, Maharashtra – Updated today
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Company Name : InspireXT Consulting
Location : Pune, Maharashtra
Position :
Job Description : Job Information
Job Opening ID
ZR_103_JOB
Number of Positions
1
Target Date
31/03/2022
Skillset
System Validation
Work Experience
3+ years
Industry
IT Services
Currency
INR
City
Pune City
Province
Maharashtra
Country
India
Postal Code
W1
Job Description
InspireXT is a Supply Chain focused company adding value to customers in Europe and the US markets. We believe in making the world’s supply chains more agile, more secure and more resilient. Our Connected Supply Chain solution enables companies to offer seamless Customer Experience and improves conversion and efficiency. Our high calibre team has been delivering some of the most advanced transformation programmes and has the experience and expertise to add value to any enterprise willing to adapt and adopt modern scenarios.
InspireXT brand will continue to evolve whilst solving real problems, innovating new solutions and continue to serve with dedication our extended network of stakeholders, Customers, Communities and Colleagues.
A new role has opened up for the Computer System Validation Lead in our Global Delivery & Innovation Centre in India. Listed below are key activities which you will be leading in order to drive success for our customers:
Develop validation protocols including master plans and testing protocols complying with regulatory requirements such as GAMP and FDA
Work with Client QA or Validation team and establish project validation processes for ERP solutions
Collaborate with external partners in jointly managing and executing validation activities
Perform risk analysis of solutions and proactively aligning testing strategies
Manage requirement traceability matrix and qualification issue resolutions
Prepare as well as assist clients in preparing regulatory audit documentations
Build Computer System Validation competency for InspireXT
Deliver training to project teams to enhance regulatory compliance in solution deliverables
Develop thought leadership and solution content from time to time
Perform reviews including documents, tests, solutions and code where feasible
Create a reusable test library with the help of the Solution implementation team
Prepare validation and test reports to seek and secure sign off from stakeholders
Drive clients’ and colleagues’ success, delivering meaningful business outcomes
Requirements
8+ years Strong experience with up-to 5+ years in Computer System Validations complying with GAMP/FDA
Expert knowledge of Software Development & Implementation Lifecycle processes is a must
Understanding of ERP use cases for Pharmaceutical business will be an added advantage
Understanding of business processes across Products based manufacturing and global supply chain businesses
Ability to inspire a team of broad skilled resources including customer stakeholders
Excellent spoken and written communication skills
Self-starter, excellent interpersonal skills and results oriented
Benefits
As part of a growing, ambitious and progressive organisation, you will benefit from diverse growth and learning opportunities, an industry leading compensation package coupled with additional benefits such as health and life insurance. Visit our Careers page to learn more.
I’m interested
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