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Contact Info
Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Pharmaceutical Consultant RP/RPi


Reference:A000249SC Location: United Kingdom
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Qualified Person

Pharmaceutical Consultant RP/RPi
Our client a pharmaceutical consulting organisation are currently recruiting for a Pharmaceutical Consultant to join their team on a permanent basis. This role is based in the UK, the successful candidate must be able to commute to one of the following office Buckinghamshire, Hertfordshire or Cornwall. It is fully remote with occasional travel to client sites and ability to go to the office when required. A more detailed job description is available upon request.

RP/RPi Responsibilities

  • Ensuring that medicinal products have been QP released in accordance with Article 51 of Directive 2001/83/EC
  • Complete supply chain check to ensure the batch is not subject to recall or reported as stolen and is available on the market in the listed country’s licensed supply chain
  • Confirm the status of unique identifiers for Prescription Only Medicines (per Commission Delegated Regulation EU 2016/161) if required for parallel import, special clinical need or for introduction
  • Ensure that any additional requirements imposed on certain products by national law are adhered to

Other Responsibilities
  • Liaise with customers in relation to their requirements, determine their needs and timelines and manage client projects including the preparation of project proposals and the implementation of Project Plans including timelines and costings
  • Conduct Quality Audits for Customers in line with the organisations auditing procedures and in line with all Pharmaceutical Regulatory requirements and standards, to highlight deficiencies to the customers and to support (as required) in the remedy of those deficiencies
  • To act as a QP/RP/RPi as nominated on client authorisations
  • To advise and support companies in the establishment and improvement of their Quality Systems
  • To follow-up with existing customers to ensure satisfaction with service
  • Prepare draft training material for external class-room based courses and for web based e-learning and downloadable training material
  • To co-deliver / deliver training to clients
Requirements
  • 3rd Level Qualification in Science or Quality Management
  • 10 years experience in Quality Assurance or Quality Compliance role – GMP/GDP
  • High level Computer Literacy and competency – Microsoft Office, Microsoft Project.
  • QP or RP Status
  • Vendor Auditing Experience
  • In-depth understanding of regulatory requirements applicable to the Pharmaceutical Industry, and knowledge of the sources of regulatory information (medical devices and cosmetics industries also considered)
  • In-depth understanding of the purpose, objectives and scope of Quality Systems
  • Demonstrated ability in effectively resolving compliance issues
  • Working with third parties
  • Creation of third party contracts / project agreements
  • Working in cross-functional teams
  • Contributing to company programmes or projects
  • Managing change, influencing stakeholders and delivering results
  • Strong Communication Skills – strong business English capability
  • Strong technical writing skills
  • Project Management Skills
For more information, please contact Sinéad Cullen on +353879500821 or [email protected]