Computer System Validation Lead

TechDigital Group; Raritan (NJ); On-site; USD 80,000 - 120,000; Full time

Job summary

An established industry player seeks a seasoned professional with over a decade of experience in Computer System Validation within the Pharmaceutical sector. This role involves supporting and validating critical regulatory systems, guiding project teams through the SDLC process, and ensuring compliance with industry standards. The ideal candidate will possess strong communication skills to interact with various stakeholders and a profound understanding of regulatory requirements. If you are passionate about improving processes and driving project success, this opportunity is perfect for you.

Qualifications

• 10+ years in Computer System Validation in the Pharmaceutical industry.
• Strong understanding of regulatory compliance and SDLC processes.

Responsibilities

• Support and validate regulatory systems while ensuring compliance.
• Guide project teams on deliverables and manage project risks.

Skills

Computer System Validation

Regulatory Information Management System

Communication Skills

Risk Based Approach

Troubleshooting

Education

Bachelor's Degree in Computer Science or related field

Certification in Project Management

Tools

JIRA

SDLC Tools

Job description

1. Supporting and Validating Regulatory systems like REMS RIMS
2. 10+ years experience in Computer System Validation of Regulatory systems like Regulatory Information Management System, REMS, Publishing, eCTD systems used in Pharmaceutical industry.
3. 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 and industry standards (i.e., GAMP).
4. Strong understanding on 21 CFR Part 11 and Risk Based Approach with the ability to guide the project teams.
5. Possesses strong communication skills to interact with business stakeholders (Technology Leader, Project Manager, Business Owner, Business users, SME) and interpret business rules and requirements and documents them for software development.
6. 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.
7. Should be able to handle and guide multiple GxP projects.
8. Ability to work with project team to facilitate interaction between Project team and Business Stakeholders.
9. Ability to manage and provide guidance, train the team on Policies, end to end SDLC Process, Procedure and Tools.
10. Trains the project team on the relevant procedures associated with different SDLC processes and Tools. Strong in Project Management tools like JIRA.
11. Manage Project priorities based upon identified risks.

Soft Skills:
(1.) To troubleshoot and resolve critical and complex tickets.
(2.) To create the root cause analysis for critical issues or faults (hands-on working).
(3.) To implement any necessary preventive measures to reduce future defects.
(4.) To provide technical assistance to the team members in resolving customer issues.
(5.) To execute continuous improvement activities and to improve the team's performance.