QA Programme Manager


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https://www.teamhorizon.ie/job-search/155-qa-programme-manager/quality/cork/job2021-06-03 15:51:521970-01-01Team Horizon
Job TypeFixed Term
AreaCork, IrelandCorkIreland
SectorQualityOperations & Manufacturing
Start Date
AdvertiserAshling Guthrie
Job Ref#2073
Job Views206
Description
Are you a natural leader who is passionate about Quality? Would you like to join a Global pharmaceutical company that offer limitless potential? If the answer is yes, Team Horizon currently have an opening for a QA Programme Manager to work at our client’s manufacturing facility in Cork.

In this role you will lead the Site Quality Programs and be a site SME on Quality related issues, and contribute to the successful delivery of site capital projects and Network programmes. You will provide technical leadership to functional areas and collaborate with key stakeholders, as well as promote department goals by selecting, motivating, and training capable staff.

 

Why you should apply:



  • Join a progressive company with a culture of diversity & inclusion who consistently features as a great place to work.


  • The role is generously compensated, and attracts a competitive base salary and highly attractive benefits package.


  • Excellent career progression opportunities.


 

What you will bedoing:



  • Liaison with other Sites and 3rd Parties


  • Quality Planning and Quality Risk Assessments for key transfer activities,


  • Technology Transfer and Test method transfers and/or Validation activities,


  • Ability to devise and implement systems e.g. Complaints, track and trend


  • Regulatory strategies and input to Filings


  • Equipment requirements for new projects


  • Project Timelines and Budgets


  • RCE generation and purchasing


  • Input to Process Validation strategy, cleaning and containment strategy


  • Ability to understand current challenges with process and recycle any known issues into FMEA reviews


  • Compliance and Inspection readiness


  • Participate fully and chair relevant Project team meetings and CRB as required


 

What you need to apply:



  • Bachelor’s Degree in Chemistry or related Science discipline


  • Proven Experience working in QA Operations


  • Minimum 5 years’ experience in QA GMP regulated environment.


  • Strong manufacturing knowledge,


  • Experience with Solid Dose


  • Track record of delivering Key Global projects and programmes


  • Quality Risk Management experience


  • Experience & knowledge of QA programmes


  • Automation experience is desirable


  • QP qualified preference but not essential


  • Competent in key quality systems such as Validation, QRM, Data Integrity , CAPA and change control


  • Experienced in supporting Capital projects, CSV qualifications


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