SKILLS BRIEF

• Over 2 years plus validation experience in medical device plastics processing, molding or assembly operations.
• Proven of knowledge of cGMP and regulatory requirements relating to the medical device industry.
• Strong documentation and review skills and experience.
• Experience of the development and maintenance of a site validation master plan within the Medical Devices or Life Sciences manufacturing sector.

THE ROLE

• QA Validation Engineer
• Sligo
• Onsite Role
• Permanent or Contractor Opportunity

ROLE BRIEF

In this role you will be responsible for coordinating the development and maintenance of the site validation program for an NNIT client. Your role will be to ensure external regulatory, quality, and compliance requirements are met. You will be directly involved in the Coordination, implementation and development of the site Validation Program and general Quality Assurance activities.

Core Tasks:

• 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.
• Documenting all activities in line with cGMP requirements.
• Maintaining the overall cGMP compliance of the production areas.