Responsible Person

Responsible Person (RP) & Responsible Person for Import (RPi)

Full Time Permanent

UK

The Role

The RP/RPi is an integral member of the Quality Team, dealing with GDP aspects for Suppliers and Customers, Import and Export of licenced and unlicenced Medicines, Medical Devices and other Healthcare products. Tasks vary greatly from day to day and, once full training is given, the incumbent will be expected to organize their own workload, and provide management and guidance to a small team of Quality colleagues.

Responsibilities

• Customer/supplier approval and categorization for products allowed according to licensure
• Customer complaints investigation and closure
• Reviewing product returns forms
• Investigate temperature excursions
• To handle and action product recalls on behalf of Suppliers
• To authorize product returns credits and product destructions
• To provide assistance / guidance to company personnel
• Trending and monitoring activities within the department
• To handle Pharmacovigilance Adverse Event and Product Quality Complaint monthly reports
• QMS, change control, CAPA, deviations – including closure
• Ensure all processes and procedure are aligned with Uniphar Group objectives
• Quality Risk Assessments
• Other duties as instructed by the UK Head of Quality or Senior Quality Leadership
• To carry out the relevant GDP SOP's as instructed by the RP of the Company.
• As Responsible Person; ensure:
  • that the QMS is maintained,
  • ensure accuracy of contemporaneous records,
  • training is adequate and delivered,
  • coordinate recall activity promptly,
  • customer complaints are effectively dealt with,
  • customers and suppliers bona fides are present, up to date and approved,
  • outsourced activities are risk assessed and approved,
  • self-inspection programs are performed,
  • keep records of delegated duties,
  • perform dispositions of returned, rejected, recalled or falsified goods,
  • approve returned goods back to saleable stock,
  • Operations activities follow validated processes and are regulatory compliant,
  • ensure relevant national laws of supply are adhered to.
  • Other duties which may be reasonably required from time to time by company managers, including delegated duties during the absence of colleagues.

Key Skills & Experience

Essential:

• Proven experience of working within quality assurance in pharma industry
• Ensure the quality management system is adequate for the licensable activities including quality risk management, documentation, deviations, CAPA, change controls and key performance indicators
• Ensure appropriate standards of GDP are maintained in the premises and any contracted premises
• Ensuring complaints, recalls and suspected falsified medicines are dealt with effectively
• Ensuring that any additional requirements imposed on certain products are adhered to (e.g. controlled drugs, unlicensed medicines)
• The individual must have previous experience named on a licence for import and export activities
• Eligibility to be Responsible Person Import (RPi)
• Experience in working with Unlicensed medicinal products
• Experienced in Internal auditing of GDP Quality systems
• Essential PC skills, including Microsoft Office, Excel and Outlook.
• Ability to quickly adapt to the new processes and various IT systems.
• Excellent organisational skills.
• Excellent attention to detail.
• Ability to appropriately apply risk management methodologies
• Good understanding of confidentiality.
• Adapt to working under pressure in a fast-paced environment.
• Ability to work independently and alignment to company objectives
• Coaching skills

Desirable:

• Experience of using Q-pulse
• Eligibility to be a Quality Controller on an MS License (secondary packaging)
• Auditor qualification
• Presentation of training to staff inside/outside the Quality department

Uniphar Background

Uniphar group is a rapidly expanding global healthcare services business with a proud heritage in Ireland.  Since IPO in 2019, the group has grown both organically and through a series of strategic acquisitions, which continues to strengthen Uniphar's international reach. With a workforce of close to 3000 employees spread across Ireland, United Kingdom, Netherlands, Nordics, and the USA, Uniphar is a trusted global partner to pharma and medtech manufacturers, working to improve patient access to medicines around the world. Uniphar provides outsourced and specialised services to its clients, leveraging the strong relationships with 200+ of the world's best known pharmaco-medical manufacturers across multiple geographies, enabled by our cutting-edge digital technology and our highly expert teams.  Uniphar is organised into three key divisions; Supply Chain & Retail, Commercial & Clinical Med Tech / Pharma; and Product Access.

Culture at Uniphar

Ethics and integrity sit at the heart of Uniphar's culture, with our customers and patients integral to what we do and how we do it.  We pride ourselves in being truly entrepreneurial, innovative, collaborative, with a strong problem-solving ethos.  Everything Uniphar does is enabled by our people and as we continue to grow domestically and internationally, we become more diverse.  This diversity fuels our business and culture.