Head of Quality

4 months ago

Galway, Ireland TEAM HORIZON Full time
Description

Team Horizon is seeking a Head of Quality for our Clients manufacturing facility in the Midlands. In this role you will oversee the Quality Assurance and Quality Control Teams & support the implementation, maintenance, and continual improvement of the company QMS and undertake the role of QP named on the relevant MIA(s).



Why you should apply:



Opportunity to work with a portfolio of products which is diversified across multiple therapeutic areas, with particular strengths in analgesics and anti-infectives.
Excellent chance to utilise QP Eligibility and Leadership experience in a Head of QA position overseeing the Quality Assurance and Quality Control Teams
Highly competetive salary & benefits on offer

What you will be doing:



Ensure an appropriate compliant QMS is in place on site to ensure best possible outputs in terms of site compliance (including Regulator Inspections) and throughput of product
Perform QP certification of product for release to market, as necessary to meet business requirements and in accordance with the Purchasing release schedule.
Site quality operations and batch certification: Manage and co-ordinate activities of the Quality team ensuring all arrangements are in place for the allocation of activities to ensure compliance and timely batch release.
Ensure Review (or delegate) batch documentation relating to the manufacture and testing of each product batch in accordance with the relevant release procedures and confirming certification of product batches by recording in the relevant QP register. Ensure QP Batch Certification of manufactured product batches for release to saleable stock after confirming the batch has been manufactured and tested in accordance with principles and guidelines of GMP, the requirements of its MA and other applicable national legislation. This will include completion of Batch Certification along with other QP’s.
Ensuring any issues that may impact release are communicated to management and Supply Chain.
Foster and promote GMP, GDP and the associated Quality Management Systems within the site. Challenge ways of working to seek improved compliance and performance where necessary, ensuring that the Quality System is implemented and maintained in relation to the manufacture and batch certification.
Support and undertake investigations relating to quality non-conformances, complaints, recalls and product batch investigations.
Review and approval of QMS documentation relating to Quality activities.
Establish and Monitor appropriate KPIs for all Quality activities. Ensure effective site Change Review Board in operation and coordinate generation and maintenance of Technical Agreements for all quality related activities
Coordinate the management of complaints, manage through to closure any Recalls relating to activities.
Ensuring Ontime completion of Internal and External audit program(s), as defined in the company audit schedule.
Support ongoing preparation for regulatory, company and customer audits of the company sites, ensuring timely audit response and completion of agreed actions on time.
Ensuring training programs available and completion of site training on core QMS processes and SOP’s.
Ensure implementation of management review process through tiered Group Quality Review Meetings.
Ensure that adequate records are maintained in relation to the management of authorised activities and that such records are accurate.
Maintain current awareness of applicable legislation, guidelines and current industry practices.
Complete additional tasks as assigned by line manager.

What you need to apply:



Eligible to be named on a manufactures licence as Qualified Person under EU Council Directive /83/EC as amended.
Quality Management experience in the pharmaceutical industry 5 years minimum.
QC experience desirable
 Regulatory experience desirable. 
The role demands a well-organised approach, underpinned by the ability to communicate effectively with people at all levels, both verbally and in writing. Reliability, IT literacy and the ability to plan and complete projects to set timelines is essential.

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