- Reference: SJ43915
- Job Type: Contract
- Location: Leitrim, Mayo, Sligo
- Category: Engineering, Technical & Manufacturing
Our client based in Sligo require a QA Validation Specialist for a 6 month fixed term contract.
- 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.
- 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 firstname.lastname@example.org
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