Senior External QA Specialist
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| Job Type | RemoteContractor |
| Area | Dublin, Ireland |
| Sector | Quality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | 3030 |
| Job Views | 963 |
- Description
- Team Horizon is seeking a Senior External QA Specialist for our client who are a global biopharmaceutical company based in Dublin. In this role you will provide Quality oversight across a complex and expansive global footprint. Whether it is supplying an early phase clinical trial, manufacturing a commercial product, or distributing product in market, the Quality organization plays an important role to ensure company provides safe, quality products to patients in a compliant way.
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:
External Supply Quality provides Quality oversight to external manufacturing portfolio across DS, DP and FDP for small and large molecule
Perform tactical batch disposition activities in support of lot release
Review and approval of LIMS data
Manage and own Deviation records
Manage and own CAPA records
Manage and drive Quality records to closure independently
Support Quality Site Leads with oversight of our external partners
Collaborate with Complaints team to request assessments, reviews complaint report and have comments addressed
Author and review QA related procedures
Escalate risks or roadblocks to management
Drive timely decision making using DAI principles
Support OpEx programs and champion continuous improvements and initiatives
What you need to apply:
4+ years of quality and manufacturing experience in biotech or pharmaceutical industry
Bachelor’s Degree in a Science Field
cGMP Experience
Ability to oversee multiple projects simultaneously.
Able to successfully manage workload to timelines.
Familiarity with basic project management tools
Ability to negotiate a position after taking feedback from multiple sources.
Demonstrated ability to consistently deliver on-time, and high-quality results.
Ability to operate in a matrixed or team environment.
Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
Ability to travel +/- 10% of time to domestic and international sites
