Quality Assurance Compliance Manager


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https://www.teamhorizon.ie/970-quality-assurance-compliance-manager/quality/dublin/job2023-05-31 16:35:121970-01-01Team Horizon
Job TypePermanent
AreaDublin, IrelandDublinIreland
SectorQuality
Start Date
AdvertiserAshling Guthrie
Job Ref#2947
Job Views838
Description
Do you possess a high level of expertise in Quality Assurance?

Team Horizon is recruiting for a Quality Compliance Manager on behalf of a multinational leader in the pharmaceutical industry.

This is an exciting opportunity for an innovative thinker and problem solver to join a high achieving team at their manufacturing facility based in Dublin.

 

Why you should apply:



  • Join a company whose goal is to help patients live healthier lives and are proud to be a Great Place to Work.


  • Be part of a diverse and dynamic team where you will have the opportunity to work with experienced leader in a globally recognised biotech company.


 

 

What you will be doing:



  • Responsibility for the delivery and leading the QA aspects of the Quality System including:

    ·         Management Review

    ·         Supplier Program

    ·         CAPA

    ·         Change Control and Documentation

    ·         Complaints

    ·         Training

    ·         Inspection Readiness & Management

    ·         Internal Audit

    ·         Quality & Technical Agreements

    ·         Continuous Improvement and Simplification Initiatives


  • Developing and managing a Quality System, ensuring compliance by all departments and personnel


  • Preparation and maintenance of Site Master File, Quality Manual and Quality Plans


  • Ensuring that products manufactured meet requirements of end users, Regulatory Authorities and of the company.


  • Developing and maintaining performance measurements of the quality system and reporting on this at the management review meeting and during quality performance meetings.


  • Act as Designee for Associate Director QA Compliance as required.


  • Adheres to and supports all EHS standards, procedures and policies.


  • Works directly with the Quality Operations Manager to support day to day site activities


  • Expertise in Assessing Quality Issues: A high level of expertise is required to assess day-to-day quality issues effectivel, utilising knowledge and understanding of quality standards, processes, and regulations.


  • Innovative Thinking and Problem Solving: The role requires innovative thinking, where new and untested solutions are proposed, demonstrated, and implemented regularly·


  • Lead, manage and develop a team of professionals and direct reports within the QA compliance group as assigned


  • Responsible for setting annual goals, completing reviews, growth plans and performance management of the team


  • Quality risk managment (within the team) , support / approve LIRS, develop and roll out metrics and support PQR.

     


 

 

What you need to apply:



  • Third level qualification in a science discipline with 8 years’ experience in the healthcare / pharmaceutical industry.


  • Degree or Masters level.


  • Being QP eligible is desirable.  ·        


  • 8 years industrial experience gained in an FDA and EMA approved pharmaceutical or device environment. 


  • Minimum 2 years supervisory experience.      


  • Demonstrated Audit/ Inspection Management experience.       


  • Requires total commitment to quality and maintaining a high standard of work at all times.  


 

 
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