Manufacturing Specialist
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| Job Type | Contractor |
| Area | Dublin, Ireland |
| Sector | QualityOperations & Manufacturing |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #2174 |
| Job Views | 597 |
- Description
- Team Horizon currently has an exciting opening for a Manufacturing Specialist to work on our client site in Dublin. The Manufacturing Specialist will be primarily responsible for resolving fill/finish nonconformances (NCs).
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 bedoing:
Specific responsibilities include but are not limited to:
Working closely with Quality, Engineering, Process Development, Validation, and Manufacturing to resolve nonconformances in a timely manner
Leading investigation teams in order to determine root cause, product impact potential, and Corrective and Preventative Actions (CAPA)
Assuring appropriate escalation to various levels of management when timeline requirements for NC processing are exceeded
Assisting as needed in audit by external agencies in answering questions related to NCs
Performing other duties as required by Manufacturing Management Basic
What you need to apply:
Bachelor's Degree in Science or Engineering and experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality)
Experience in managing multiple, competing priorities in a fast-paced environment
Strong technical writing and presentation skills
Ability to be flexible and manage change
Ability to communicate and collaborate with technical and management staff
Experience with investigations into manufacturing deviations and determination for product impact potential, root cause, and corrective actions
Experience interacting with representatives of regulatory agencies
