QA Validation Engineer

Description

• Generation/maintenance/execution of the Site Validation Master Plan.
• Generation of validation protocols and final reports to cGMP standards.
• 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 Project Validation Plans and schedules.

Requirements

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

Benefits

Training + Development

Interview process

Visa Sponsorship

Security clearance