PE Global is currently recruiting for a QA Validation Engineer for a leading multi-national Pharma client based in Sligo. This is a 12 month contract position. Role: To coordinate the development and maintenance of the site validation program and ensure the clients and external regulatory, quality, and compliance requirements are met. Coordination, implementation and active participation in the site Validation Program and general Quality Assurance activities.
Responsibilities: Coordination / direction and active participation in the validation and quality assurance of site equipment, utilities, processes and software in compliance with client policies, FDA, European cGMP and GAMP standards. 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. Generation of validation investigations and implementation of corrective actions. Creation/Review/Approval of various quality documents and test data. Management of validation, exception event, and change control processes. Maintenance and tracking of validation equipment, if applicable. Completing all required training before executing a task. Documenting all activities in line with cGMP requirements. Updating of validation procedures, job instructions and batch documentation to reflect current best practices. Requirements: Qualification and/or degree in engineering or scientific discipline. 3 years plus of knowledge of cGMP, validation and regulatory requirements relating to the biopharmaceutical industry. Strong communication (written and oral), presentation and troubleshooting skills required. Effective interpersonal and organizational skills. Ability to work well both independently and in a team environment. Capable of prioritizing work and multitasking. Interested candidates should submit an updated CV.
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