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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Quality Specialist dRP


Reference:SCA013970 Location: Dublin
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: QA Specialist, Quality Assurance Officer, Quality Specialist, Quality Systems Specialist

Quality Specialist Deputy Responsible Person (dRP)
Our client, a leading and expanding pharmaceutical (Distribution) organisation, are currently recruiting for a Quality Specialist Deputy Responsible Person (dRP) to join their team on a permanent basis.
As Quality Specialist Deputy Responsible Person (dRP) you will be responsible for the quality oversight of the distribution of products within the Supply Chain. You will ensure product shipments are managed in compliance with GDP requirements and in line with the organisations procedures.


Responsibilities

  • Assist in the development, implementation and maintenance of the Quality Management System
  • Ensure Good Distribution Practice (GDP 2013/C 343/01) and current Health Products Regulatory Authority (HPRA) guidelines (IA-G0046) are adhered to covering all GDP activities performed
  • Assist in ensuring the Quality processes are compliant and well understood across the business through continuous training, retraining and informative communications.
  • Ensure all staff are initially trained upon commencement of employment and that a continuous training program is in place for all current and new employees
  • Ensure that only the relevant authorised product classes are procured from approved suppliers and supplied to approved customers and are covered under the Company’s Wholesale Distribution Authorisation
  • Assist in the approval of outsourced service providers and assist in route qualifications of transport providers as planned and required
  • Review, Draft and Approve documentation including change controls, deviations, validation documentation, SOP’s etc
  • Complete relevant initial and ongoing Bona Fide checks on suppliers and customers as assigned
  • Ensure and maintain a companywide risk management culture
  • Review and update Quality Technical Agreements as required and ensure Technical Agreements are in place with all suppliers, customers, and outsourced service providers
  • Returns – Identify returns within the supply chain and manage accordingly, reporting same to the RP as they arise, ensuring all returns are held in the secure returns area awaiting their fate, ensuring returns are not made available for sale unless approved by the RP
  • Assess temperature-controlled shipments and provide corresponding quality decision on product
  • Monitor and assess all temperature-controlled activities within the supply chain including the monitoring of the organisations warehouse temperature
  • Escalate any known or suspected Adverse Reactions (ADRs) and or serious Product Quality defects to the RP for onward reporting to the relevant Competent Authority and the relevant Product Authorisation holder as applicable
  • Recalls – ensure coordination and actioning of any recall activity for medicinal products are conducted immediately upon notification within a controlled and compliant manner
  • Act as dRP on the organisations Wholesale Authorisation and fulfil all the responsibilities and duties on behalf of the RP in their absence and ensure that a handover of information is completed prior to the absence and the returning of the named RP to work
  • Conduct any duties required as delegated to the dRP from the RP, keeping all records of these duties and activities appropriately recorded
  • Ensure that continuity of supply is maintained but ensure that no commercial decision made has any impact on the quality/patient/product safety
  • Escalate any known or suspected Falsified Medicines to relevant Competent Authorities and relevant product authorization holder as soon as possible
  • Ensure that a key focus is maintained at all times on the accuracy of the quality records within the organisations Quality Management System and related GDP system
  • Carry out duties / projects as assigned by the Quality Manager
Responsibilities
  • 3+ years QA experience in a HPRA/FDA/EU & GMP/GDP regulated environment
  • Thorough knowledge of temperature-controlled activities
  • Thorough knowledge of cGMPs/GDPs and global regulatory requirements
  • Sound awareness and understanding of pharmaceutical WDA business models, especially with regards to quality and regulatory requirements.
  • Strong Interpersonal skills and ability to interact constructively with all functions in a matrix organization environment
  • Good verbal and written communication skills with well-structured communication and ability to present to various audience levels
For more information please contact Sinéad Cullen on +353879500821 or [email protected]