Senior Quality Assurance (QA) Associate
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| Job Type | Permanent |
| Area | Dublin, Ireland |
| Sector | Quality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #1002031 |
| Job Views | 331 |
- Description
- We are seeking applications for our client, who is a leading biopharmaceutical company based in Dublin. You will typically report to a Snr QA manager, become a core member of the site QA team acting as point of contact for plant QA inspection operations. The site is focused on continuous improvement, so in addition to routine QA duties, you may be asked to carry out additional work functions to support site continuous improvement activities. Do note that a variety of shift patterns may be required to support operations, primarily 24/7 shift.
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
Observing and provide real-time quality oversight and support for inspection operations.
Conducting Visual AQL audits as part of the inspection process.
Carrying out QA reserve sample inspections as part of the program and in support of customer complaint investigations.
Provide Quality support for triage and investigation of all classes of deviation events
Reviewing and approving of deviations and CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable
Reviewing and approving production batch records, and associated documentation in preparation for Qualified Person disposition activities.
Providing training and advice to staff in order for them to perform their desired functions.
Writing, reviewing and approving Standard Operating Procedures.
Supporting 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
4 year + working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role
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
Ability in managing Root Cause Analysis / Deviation investigations
Knowledge of applicable regulatory requirements, and ability to evaluate compliance issues
Operational Excellence experience
