Quality Assurance Assistant

Key Performance Areas (Core responsibilities & outputs of the position)

Will support the delivery of operational excellence, working in partnership with the business areas to implement improvement opportunities and effective use of the Quality Management Systems.  The following responsibilities are key to how this support can be provided:

·       Able to plan effectively to meet set timelines.

·       Identify root-causes of a problem, prioritise and identify solutions.

·       Contribute to continuous improvement by formulating reports, trending and data analysis.

·       Support other members from the Quality team.

·       Maintain excellent working knowledge of continuous improvement tools and methodologies.

·       Effectively manage the operational tasks within the Quality Management System (QMS) including but not limited to:

o   Change Controls

o   Non-conformances / Deviations

o   Complaints

o   CAPAs

o   Risk Management

o   Effectiveness

·       Create, review and approve relevant standard operating procedures, work instructions and forms.

·       Ensure that appropriate standards of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and ISO 13485:2016 are maintained.

·       Maintain Clinigen paper and electronic records for quality documentation.

·       To communicate relevant aspects of the quality system to employees, as necessary, in order to support product and service quality.

·       Support as required in internal, external and Regulatory audit programs.  This includes report writing and managing of audit observations/ responses.

·       Escalate to management when product quality or patient safety is at risk.

The list of duties is not intended to be exhaustive, but gives a general indication of the tasks involved.  It is the nature of the company that tasks and responsibilities are, in many circumstances, unpredictable and varied.  All employees are, therefore, expected to work in a flexible way when the occasion arises and acknowledge that tasks not specifically covered in their job description are not excluded.


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