Quality Assurance Senior Associate
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| Job Type | Contractor |
| Area | Dublin, Ireland |
| Sector | Quality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | 3135 |
| Job Views | 907 |
- Description
- Team Horizon is seeking a Quality Assurance Snr Associate for our Dublin based Client who are a global leader in the field of biotechnology.
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.
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.
Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.
What you will be doing:
Perform all activities in compliance with safety standards and SOPs
Observe and provide real-time Quality oversight and support for Packaging unit operations.
Perform purposeful presence Quality walks on the shop floor to ensure permanent inspection readiness.
Participates in Customer complaint batch record review to support investigations.
Perform Packaging Quality audits on every Packed lot.
Provide Quality support for triage of atypical events
Quality oversight of minor investigations, including review and approval of Deviations for closure ensuring compliance with appropriate documentation
Review/approve production batch records, and associated documentation in preparation for Qualified Person disposition activities.
Provides training and advice to manufacturing staff in order for them to perform their desired functions.
Write, review and approve Standard Operating Procedures in accordance with Policies.
Support continuous improvement and Operational Excellence initiatives
Any other tasks/projects assigned as per manager’s request.
What you need to apply:
University degree. Engineering or Science related discipline preferred.
Relevant experience (4 yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
Excellent written and verbal communication skills.
Experience working with dynamic cross-functional teams and proven abilities in decision making.
Fluency in SAP, Trackwise, Excel, Teams, etc
Strong organizational skills, including ability to follow assignments through to completion.
Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations.
Experience working with combination products or devices in packaging-related or complaint-handling activities.
Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues.
Operational Excellence experience
