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Skills

Computerized System Validation
Software Development Methodology
Supervision
Manufacturing
MES
GxP
Inspection
Specification Gathering
Test Scripts
Risk Management
Leadership
Mentorship
Project Coordination
Management
Status Reports
Writing
Documentation
Test Plans
Regulatory Compliance
Agile
JIRA
Partnership
English
Communication
Acquisition

Summary

Summary :

Roles & Responsibilities :

Strong CSV and Quality expertise with ability to independently lead validation activities across the SDLC for GxP systems with minimal supervision. 7-10 years of relevant experience.
Proven experience with Manufacturing, MES, and Data Platform Applications, including support for global and regional GxP computerized systems.
Deep knowledge of GxP compliance, FDA/Global regulations, and Inspection Readiness.
Expertise in validation documentation and deliverables, including review of compliance plans, requirements, design specs, test protocols, test scripts, defects, traceability, reports and system procedures.
Demonstrated application of risk-based validation and risk management practices.
Effective leadership and mentoring skills, guiding cross-functional and external teams (Senior and Junior consultants).
Strong project coordination and stakeholder communication skills, including managing risks, issues, and status reporting.
Experience in writing documentation (i.e. Compliance Plan, Test Plans, Test Reports, Compliance Summary Reports, and SOPs).
Knowledge of Agile Tools (e.g., Jira, Xray, qTest, etc.).
bility to build collaborative partnerships, work as a team player and support execution of business objectives across teams, including timely escalations to TQ manager.
Primary Language required: English. Strong verbal and written communication skills.
bility to work with dispersed/remote teams and support several projects simultaneously.
Experience with Acquisitions/Separations/ Divestiture efforts is desirable.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: a2fe579d16406e97933b4917d8321b07
Posted 4 days ago

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Hybrid in Raritan, New Jersey

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