Senior QA Associate
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| Job Type | Permanent |
| Area | Dublin, Ireland |
| Sector | Quality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #1002026 |
| Job Views | 380 |
- Description
- We are seeking applications for our client, who is a leading biopharmaceutical company based in Dublin. In your new role, you will report to the QA Manager and be a core member of the site Quality Assurance team, serving as Quality point of contact for manufacturing operations. The site is focused on continuous improvement of all work processes and practices, so in addition to routine Quality Assurance duties, you may be asked to carry out additional work functions to support site continuous improvement activities. The role is 24/7 shift required to support manufacturing operations so some weekend work may also be required.
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:
Complying with safety standards and SOPs.
Writing, reviewing and approving Standard Operating Procedures
Providing support for triage and investigation of all classes of non-conformance (NC) events.
Reviewing and approving of NC1s and CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable.
Taking part in customer complaint investigations.
Giving training and advice to staff in order for them to perform their jobs.
Observing and provide real-time quality oversight, and support for production unit operations, extending to formulation, vial and Syringe Fill Finish related activities, including observation and provision of direction during media fills and assessment of aseptic interventions.
Reviewing and approving production batch records, and associated documentation in preparation for Qualified Person disposition activities.
Reviewing and approving cGMP records ensuring compliance with appropriate documentation.
Supporting continuous improvement and operational excellence initiatives.
Any other tasks/projects assigned as per manager’s request
What you need to apply:
University degree in engineering or a science related discipline preferred.
4 years+ experience working in the pharmaceutical or biotechnology industry
Brilliant written and verbal communication skills.
Experience working with dynamic cross-functional teams
Proven abilities in decision making.
Great organizational skills, including ability to follow assignments through to completion.
Proven ability in problem solving
Experience in managing Root Cause Analysis / Non-Conformance /Deviation investigations.
Experience working in aseptic operations, protein formulation, vial and syringe filling.
Knowledge of applicable regulatory requirements, and ability to evaluate compliance issues
