Job Intersection | Contract Job on CSV Leadin Katalyst Healthcares and Life Sciences

Job Summary

Location

Raritan ,NJ 08869

Job Type

Contract

Visa

Any Valid Visa

Salary

PayRate

Qualification

BCA

Experience

2Years - 10Years

Posted

01 Feb 2025

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Job Description

Responsibilities:

Supporting and Validating Regulatory systems like REMS RIMS.

Computer System Validation of Regulatory systems like Regulatory Information Management System, REMS, Publishing, eCTD systems used in pharmaceutical industry.

Guide the project team with the right set of applicable project deliverables based on project type and category while catering to the SDLC Application of FDA guidance s and industry standards (i.e., GAMP).

Strong understanding on 21 CFR Part 11 and Risk Based Approach with the ability to guide the project teams.

Possesses strong communication skills to interact with business stake holders (Technology Leader, Project Manager, Business Owner Business users SME) and interpret business rules and requirements and documents them for software development.

Expertise in documenting guiding various SDLC Deliverables including Requirements Specification User Stories, Criticality Assessment, Test Plan, Design Documentation, Validation Plan, Risk Assessment, Validation Strategy Test Planning, Validation Test Summary, Requirement Trace Matrix.

Possesses strong communication skills to interact with business stake holders (Technology Leader, Project Manager, Business Owner Should be able to handle and guide multiple GxP projects.

Ability to work with project team to facilitate interaction between Project team and Business Stake holders.

Ability to manage and provide guidance and train the team on Policies, end to end SDLC Process, Procedure and Tools.

Trains the project team on the relevant procedures associated with different SDLC processes and Tools Strong in Project Management tools like JIRA.

Manage Project priorities based upon identified risks.

Requirements:

To troubleshoot and resolve critical and complex tickets.

To create the root cause analysis for critical issues or faults (hands on working).

To implement any necessary preventive measures to reduce future defects.

To provide technical assistance to the team members in resolving customer issues.

To execute continuous improvement activities and to improve the team s performance.

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