QA Validation Specialist - Sligo

Collins Mcnicholas Recruitment

Sligo

Our client based in Sligo require a QA Validation Specialist for a 6 month fixed term contract. Key Responsibilities: Coordination / direction and active participation in the validation and quality assurance of site equipment, utilities, processes and software in compliance with 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. Performing cross training within the team and training of new team members. Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems. Coordinating activities to maximize the effectiveness of all of the team members. Maintaining the overall cGMP compliance of the production areas. Communicating with peers and management regarding activities in the area, including elevation of events or concerns. Education: Qualification and/or degree in engineering or scientific discipline. Experience & Skills: 3 years plus Validation/Quality experience in medical device industry. 3 years plus of knowledge of cGMP and regulatory requirements relating to the medical device 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. A minimum of 3 years’ experience in a cGMP regulated environment. For a confidential discussion and more information on the role, please contact Aideen Cummins on 071-9140252 or email aideen.cummins@collinsmcnicholas.ie. For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie Follow us on LinkedIn and connect with our Recruitment Consultants to discuss the latest jobs as well as our job searching tips and videos! This job originally appeared on RecruitIreland.com.

2690 days ago