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QA Responsible Person

Apply Now Email Me Job ID R0004054 Date posted 08/28/2018 Location:Wicklow, Ireland

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Job Description

OBJECTIVES:

  • Provide leadership in the development of policy, process and organization to ensure compliant operations
  • Perform all the duties and have all rights applicable to the Responsible Person in Ireland as per HPRA requirements
  • Decide on all pharmaceutical activities in scope of the License
  • Maintain locally the Quality Management System
  • Provide direction to the organization for the activities falling under the responsibility and decision making mandated by HPRA
  • Ensure all requirements to maintain the Wholesale Distribution License are met

ACCONTABILITIES: 

  • Provide expertise in Regulatory Compliance for the products manufactured and traded by Takeda
  • Perform all the duties and have all rights legally applicable to the Responsible Person
  • Accountable to ensure GxP related activities which support Takeda’s global trading of products are compliance and efficient. 
  • Ensure all requirements to maintain the Trade License of the Irish organization are met.
  • Ensure that Quality Management System is fully implemented and maintained
  • Ensure training on procedures to impacted parties
  • Ensure necessary authorisations are in place to decide on all pharmaceutical activities and ensure safe and compliant processes of trading pharmaceutical products in foreign countries
  • Review and approve relevant operational documents of GxP impact
  • Manage inspections, corporate internal audits
  • Manage  self-inspections and external audits as needed
  • Lead or support local, regional, global projects, as needed
  • Ensure availability for management of critical events requiring pharmacovigilance, escalation and/or recall, decisions and/or support.
  • Keep appropriate records and control of any delegated duties and ensure their visibility
  • Accountable for decisions related to disposition of returned, recalled or falsified product
  • Align with a broad global network of stakeholders, including management teams and business units  operating with and on behalf of the Swiss Headquarter

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Meets qualifications to be an Industry Certified Responsible Person (RP) in Ireland
  • Scientific Degree (preferably in Pharmacy)
  • Minimum 5 years' experience in a Quality Assurance/Regulatory Compliance in the Pharmaceutical industry are essential
  • GDP, distribution, warehousing and transportation experience
  • Highly punctual, systematic, highly organized, & concise in communication
  • Strong attention to details, ability to review & managing documentation

    (Including transport temperature records, shipping documents. and related GDP documents, records etc.).

  • Highly flexible, creative, and have strong desire to get results in complex & sometimes unpredictable environment
  • Broad understanding of Supply Chain related topics as well as related risks and global regulatory implications Fluent English (written & oral), additional European languages are a plus
  • International travel as required up to 30%
  • Committed team player
  • All applicants must hold a valid EU passport

*LI-AF1-EUR

Locations

Bray, Ireland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Apply Now Email Me