QA Senior Associate

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  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.


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  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.


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  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.

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  Perform all activities in compliance with the client’s safety standards and SOPs


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  Review production batch records, and associated documentation in support of complaint investigations


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  Document assessments within the complaint repository Bioconnect for batch records, root cause analysis (RCA) outcomes, technical evaluations related to complaints


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  Support Area SMEs during complaints RCA, technical evaluation by providing them with context of the complaint received within the Bioconnect system


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  Complete DV on the monthly complaints report.


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  Provides training and advice to staff in order for them to perform their desired functions. Specifically on complaints batch review and also on navigation of the Bioconnect system within our facility for other QA teams and external functions who support complaints


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  Support audits and inspections through collation and data verification of complaints data for presentation to auditors


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  Write, review and approve Standard Operating Procedures in accordance with the client’s Policies


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  Observe and provide real-time Quality oversight and support for Packaging unit operations.


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  Perform Packaging check quality audits during production of Labelled and Finished Drug Product lots.


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  Support continuous improvement and Operational Excellence initiatives


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  Any other tasks/projects assigned as per manager’s request.


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  Cross-training to support on the floor packaging operations in a limited capacity.


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What you need to apply:

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  University degree in Science or Engineering related discipline preferred.


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  Relevant experience (4yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.


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  Experience working with combination products or devices in packaging-related or complaint-handling activities.


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  Experience in using the following electronic systems, or an equivalent, as part of batch record review: SAP, Werum PAS/X Manufacturing Execution System (MES), Trackwise.


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  Excellent written and verbal communication skills.


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  Experience working with dynamic cross-functional teams and proven abilities in decision making.


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   Strong organizational skills, including ability to follow assignments through to completion and work independently.


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  Experience as a participant in Root Cause Analysis/Deviation investigations.


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  Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues.


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  Operational Excellent experience.