Responsible Person

Description Overview

The Responsible Person (RP) is responsible for ensuring compliance of Perrigo Supply Chain International DAC organisation and activities with the general conditions of the Wholesale Distribution Authorisation  and the current requirements of Good Distribution Practice as outlined in Guidelines on Good Distribution Practice of Medicinal Products for Human Use of 24 November 2013 and in Guidelines of 19 March 2015 on Principles of Good Distribution Practice of Active Substances of Medicinal Products for Human Use.

This is a very exciting opportunity to work with a global organisation where the Headquarters is based in Dublin, Ireland. There is the opportunity to develop the skill set of the RP due to the ever-changing dynamic of the business. This RP will work closely with the local and international functions to support ongoing changes due to the centralisation of supply flows. This will allow the RP to bring their knowledge and experiences into the ongoing project(s).

This role requires RP experience on a WDA, and the candidate must be based in the Republic of Ireland. 

Scope of the Role

• Ensure compliance of the organisation and activities with the general conditions of the applicable Wholesale Distribution Authorization (WDA)
• Ensure that a Quality Management System is implemented and maintained by focusing on the management of authorised activities and the accuracy and quality of records.
• Approving the initial and continuous training programme for all personnel involved in distribution activities and performing assignment and maintenance of training curricula in the Global LMS system.
• Ensuring compliance of the organization and activities with the current requirements of Good Distribution Practice, as defined by the Guidelines on Good Distribution Practice of Medicinal Products for Human Use of 24 November 2013 and in Guidelines of 19 March 2015 on Principles of Good Distribution Practice of Active Substances for Medicinal products for Human Use
• Coordinating and performing promptly any recall operations of medicinal products
• Ensuring that all customer complaints within the scope of operations are processed appropriately.
• Performing the qualification and approval of suppliers and customers
• Approving any contract between the Contract Giver and the Contract Acceptor which specifies their respective responsibilities relating to wholesale distribution and/or transportation of medicinal products.
• Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place.
• Delegating his/her duties when absent and keeping appropriate records relating to any delegation.
• Involvement in any decision to quarantine or dispose of returned, rejected, recalled or falsified products.
• Notify and consult with the HPRA on potential recalls or critical quality issues which may impact patient safety.
• Ensuring that any additional requirements imposed on certain products by national law are adhered to, as foreseen in Article 83 of Directive 2001/83/EC.
• Approving Standard Operating Procedures / Forms / Work Instructions and any applicable documentation associated with the WDA and GDP.
• Chair Management Review and ensure relevant CAPAs are assigned and adequately addressed.
• Verifying a process is in place for validation activities associated with computerised systems.
• Ensuring risk assessment philosophies and methodologies are used in line with ICH Q9
• Notify the HPRA of any change of Responsible Person or deputy by means of submission of a variation to the WDA.
• Ensuring vendors are supplied with current valid copies of the applicable WDA (upon request).
• The RP is responsible for ensuring that all relevant information regarding the period of responsibility/delegation to DRP is communicated.
• Ensuring that the relevant customers are informed in the event of a distributor becoming aware of a shortage in supply. 

Experience Required

• Primary degree or equivalent in biological or chemical sciences, pharmacy, medicinal science or a related discipline.
• Typically five years’ work experience in the field of pharmaceutical manufacture and/or pharmaceutical distribution.
• Experience in the use of root cause analysis and CAPAs in the investigation and resolution of deviations.
• Experience in the assessment of authorisations and bona fides across international markets, including non-EU jurisdictions.
• Experience in the use of standard business applications such as the Microsoft Office Suite.
• Ideally qualified as an RP or QP.
• Training Requirements:
  • Perrigo SOPs as per the RP curricula
  • Act as Responsible Person (RP) in accordance with Directive 2004/27/EC
  • Act as main contact for the competent authorities for quality for Ireland
  • To ensure compliance with the Statutory Instruments, e.g. S.I. No. 415 of 2022 MEDICINAL PRODUCTS (CONTROL OF WHOLESALE DISTRIBUTION) (AMENDMENT) REGULATIONS
  • Third Party training on the role of the RP
  • GDP training
  • HPRA guidance training