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Employers

Product Release Quality Manager/QP, Mayo

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Location:

Mayo, Ireland 

Job Category:

Biotech/Pharma, Science
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EU work permit required:

Yes
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Job Reference:

1049

Job Views:

54

Posted:

17.10.2018

Expiry Date:

01.12.2018
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Job Description:

The Opportunity

Team Horizon is seeking a Product Release Quality Manager/QP who will hold responsibility for QA activities in support of Unit Dose through the Product Release Function. The role will provide support to the QA/QP Associate Director in addition to the Business Unit Leader in achieving the required goals and objectives; meeting customer requirements and the necessary regulatory requirements as lay down by the FDA, EU and regional Ministries of Health as relevant

The Role

  • Act in the capacity of a Qualified Person in accordance with Annex 16, EudraLex, Volume 4 and directive 2001/83/EC to support disposition of Company Pharmaceutical Products
  • Manages the batch disposition process to ensure timely release of products
  • Ensures the batch disposition process maintains compliance with site practices & regulatory requirements
  • Support the deviation/ non-conformances/CAPA program
  • Support the Change Management program in the Business Unit
  • Be a SME for quality records and quality systems, ensuring consistency of records
  • Promote technical writing and quality awareness
  • Provide Quality support to site projects
  • Identify and support aseptic improvements
  • Support the Self-Inspection program
  • Inspection Management: (Coordinate site GMP inspections; Internal site preparation; pre-audit MOH requests; Response/report compilation & issuance; Post audit commitment management)
  • Quality metrics & monthly quality system & Senior Management review and Local Management Review meetings; (Meeting preparation and coordination of post meeting commitments)
  • Represent quality at daily & weekly cross functional meetings
  • Manage regulatory standard/guidance revision assessments
  • Support the site quality plan and ensure plan execution
  • Coordinate compliance initiatives
  • Support the Site Quality Risk Management Program

The Person

  • Requires BSc in scientific discipline with minimum 5 years of relevant work experience in pharmaceutical or related industry
  • Education requirements for Qualified Person eligibility
  • Experience in aseptic manufacturing and sterilisation processes (example: Filter Sterilisation) is desirable
  • Proficient in MS Office (Word, Excel, Outlook, and PowerPoint)
  • Strong Technical writing ability
  • Contentious and reliable worker
  • Excellent communication and presentation skills both verbal and written, with the ability to engage with a diverse range of individuals across all levels of the organisation
  • Ability to develop a good working relationship across functions
  • Ability to understand and articulate quality requirements in a clear, consistent and coherent manner

Employment Type:

Full time
Company Info
Team Horizon
1 Cedar Crescent, Cedar Park, Westport, Co. Mayo
Westport, Ireland
Phone: +353 98 50600
Web Site: http://www.teamhorizon.ie
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