QA Senior Associate (Packaging & Complaints)
This job does not exist anymore.
Try running a new searchor browse our vacancies.
Or fill in the form below to receive job alerts.
| Job Type | Contractor |
| Area | Dublin |
| Sector | QualityOperations & Manufacturing |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #2150 |
| Job Views | 586 |
- Description
- Team Horizon have an exciting opportunity available for a QA Senior Associate for our Dublin based Client who are a Global leader and pioneer in the Biopharmaceutical industry. In this role you will serve as Quality point of contact for Packaging operations, as well as supporting the complaints’ function.
Why you should apply:
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 Company safety standards and SOPs
Observe and provide real-time Quality oversight and support for Packaging unit operations.
Participates in Customer complaint investigations.
Perform Packaging check audits.
Provide Quality support for triage and investigation of all classes of deviation events
Review and approval 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
Review/approve production batch records, and associated documentation in preparation for Qualified Person disposition activities.
Provides training and advice to staff in order for them to perform their desired functions.
Write, review and approve Standard Operating Procedures in accordance with Company 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
Excellent written and verbal communication skills
Experience working with dynamic cross-functional teams and proven abilities in decision making
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
A variety of shift patterns may be required to support packaging operations, including but not limited to day shift, 16/5 shift. Weekend work may also be required.
