Senior Associate, Quality Assurance
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| Job Type | Contractor |
| Area | Dublin, Ireland |
| Sector | Quality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #2041 |
| Job Views | 332 |
- Description
- We are seeking applications for an experienced Senior Associate, Quality Assurance for our client, who are a pioneer in the Biotechnology industry. This role will be based in their aseptic drug product operations facility in Dublin.
Why you should apply:
State of the art working facilities, including Next Generation office areas and on-site gym.
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.
There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
What you will be doing:
Delivering all activities in compliance with safety standards and standard operating procedures (SOPs).
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:
University degree, preferably in an Engineering or Science related discipline.
Must Pass Eye-Tests for Visual Inspection
Relevant experience 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
