QA Validation Specialist – Sligo | Collins McNicholas

QA Validation Specialist – Sligo

  • 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.

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

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Contact Consultant

  • Aideen Cummins
  • Principal Recruitment Consultant
  • 071 9140252
  • Connect with Aideen
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