QA Validation Engineer

Overview

Validate equipment, utilities, processes and software per cGMP, FDA, GAMP standards

Key Responsibilities

• document review
• validation coordination
• investigation
• master plan
• project validation
• report generation

Tasks

-Creation/Review/Approval of various quality documents and test data. -Coordination / direction and active participation in the validation and quality assurance of site equipment, utilities, processes and software in compliance with company policies, FDA, European cGMP and GAMP standards. -Generation of validation investigations and implementation of corrective actions. -Generation/maintenance/execution of the Site Validation Master Plan. -Generation/maintenance/execution of Project Validation Plans and schedules. -Generation of validation protocols and final reports to cGMP standards.

Requirements

• cgmp
• medical device
• validation
• plastics
• engineering degree
• communication

What You Bring

-Strong knowledge of cGMP and regulatory requirements relating to the medical device industry. -Strong communication (written and oral), presentation and troubleshooting skills required -Capable of prioritising work and multitasking -Effective interpersonal and organisational skills. -Extensive validation/Quality experience in medical device plastics processing, moulding or assembly operations. -Ability to work well both independently and in a team environment. -Qualification and/or degree in engineering or scientific discipline.

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About Qcs Staffing

-Founded with the aim of providing top-tier staffing solutions for diverse sectors. -Focus on long-term partnerships with clients, ensuring the right talent for specialized roles. -Expert in recruiting for both large-scale projects and niche, high-demand sectors. -Has become a trusted partner in sectors such as Industrial, Energy, and Infrastructure. -Notable for a rapid response to market demands and changing industry trends. -Experience in delivering recruitment services for large infrastructure and energy projects. -Specializes in sourcing skilled professionals for both permanent and temporary roles. -Recognized for working on complex and large-scale projects with a diverse client base.

Sector Specialisms