Quality Assurance Manager
Hobson Prior are currently looking for a Quality Assurance Manager to join a brilliant pharmaceutical organisation on a permanent basis. Our client is focused on providing healthcare products for people who are severely ill.
Please note that to be considered for this role you must have the right to work in this location.
- For this role, you will supervise compliance with the quality management system, trend complaint and deviation data, produce trend analysis reports as well as guarantee that efficient corrective measures are applied.
- Collaborate cross-functionally with any other divisions and third parties to reduce any non-conformances which might impact the quality management system, mitigate patient risk and assure compliance with regulatory standards, food standards and ISO 9001.
- Handle compliance of all divisions to regulatory standards and guidelines by guaranteeing that high quality standards and cGMP are upheld.
- Offer managerial, training, leadership and guidance to the QA team, guaranteeing that there is sufficient resource with adequate expertise and familiarity, to uphold the operational area of product release and compliance with cGMP/ISO 9001 standards.
- Handle the company's complaint and deviation management systems.
- Guarantee solid and efficient complaint and deviation management systems are in place to meet customer and regulatory needs.
- Arrange all third-party audits such as MHRA inspections and formulate any resultant action plans with realistic timelines.
- You will approve all SOPs for the aseptic production sector and any other connected operational areas.
- Recognise, design and deliver GMP training to personnel to assist with improved application of GMP/GDP standards.
- Perform risk assessments and gap analysis of the present quality systems and formulate action plans accordingly.
- Handle and control the site master file as well as the quality manual and the execution of the resulting quality systems.
- A background in pharmaceutical organisations, ideally educated to a degree level in a scientific or pharmacy field.
- Familiarity with QMS elements and affiliated e-platforms such as TrackWise and Documentum is desirable.
- Acquaintance with both internal and external audit management.
- Previous involvement in a line management role.
- A background in pharma or biologics.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
€40000 - €50000 per annum
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