QA Compliance Specialist
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| Job Type | Fixed Term |
| Area | Dublin, Ireland |
| Sector | Quality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | 2855 |
| Job Views | 698 |
- Description
- Team Horizon is seeking a Senior QA Associate for our clients aseptic manufacturing facility in Dublin. In this role you will be responsible for the inspection and release of primary packaging components. You will report to a QA Senior Manager and will serve as Quality point of contact for Incoming Inspection of Primary and packaging components.
Why you should apply:
This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
What you will be doing:
Testing of primary and secondary components for use in the manufacture of aseptic products
Sampling of Excipients and Drug Substance under Grade C conditions.
Review/approve documentation associated with component testing in preparation for QA Specialist or Qualified Person disposition activities
Compiling, Review and approval of minor NC and CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable
Provide training and advice to staff in relation to testing of components and packaging.
Actively participate in audits and their preparation.
Review cGMP records (e.g., WO, JP, GDMS, NC, CAPA, protocols, reports, SOP, etc.) ensuring compliance with appropriate documentation
Write, review and approve Standard Operating Procedures in accordance with company Policies.
Perform all activities in compliance with safety standards and SOPs
Support continuous improvement and Operational Excellence initiatives
Any other tasks/projects assigned as per manager’s request.
What you need to apply:
Basic Qualifications & Experience:
Must Pass Eye-Tests required for Visual Inspection
University degree. Engineering or Science related discipline preferred.
Relevant experience (4 yrs. +) working in the pharmaceutical or biotechnology industry
Excellent written and verbal communication skills
Experience working with dynamic cross-functional teams and proven abilities in decision making
Strong organizational skills, including ability to follow assignments through to completion
Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non-Conformance /Deviation investigations
