UK QMS Lead

Reposted 11 Days Ago
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2 Locations
In-Office or Remote
Mid level
Healthtech • Pharmaceutical • Manufacturing
The Role
The UK QMS Lead oversees Quality Management Systems for GDP-related activities in the Uniphar UK business, ensuring compliance with various standards and managing customer complaints, self-inspections, and team supervision.
Summary Generated by Built In

UK QMS Lead

Full Time Permanent

The Role

The UK QMS lead is an integral member of the Quality departments across the Uniphar UK business, responsible for managing the Quality Management Systems for GDP related activities across the UK businesses. The key aspects of the QMS included within the management responsibility are the Quality Management Review, Complaints management, Self-inspections, training, incidents & CAPA, change management and document management. Tasks vary greatly from day to day and the incumbent will be expected to organise their own workload and provide management and guidance to a small team of Quality colleagues.

Key Outcomes

  • Act as UK QMS Lead for Uniphar UK including Doncaster Pharma Ltd, Dial-a-Chemist UK and MedTech UK (and additional business units as acquired in the future)
  • Manage the Quality Management Systems on Q-Pulse across all UK entities which operate under a ISO 13485, ISO 9001, GPhC, WDA(H) or MS license.
  • Manage customer complaints, incidents, CAPAs and change management across the UK business entities
  • Performance of Risk Assessments when required.
  • Management and supervision of relevant members of the Quality Assurance teams
  • Ability to provide leadership and support to the business in line with Uniphar’s global quality strategy
  • Manage/perform internal self-inspections
  • Collate information and host Quality Management Review
  • Be eligible to act as RP on business WDA(H).
  • As a 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 and international laws of supply are adhered to,
    • ensure business is GDP and ISO 9001 compliant

Other duties which may be reasonably required from time to time by company managers, including delegated duties during the absence of colleagues.

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.

Top Skills

Iso 13485
Iso 9001
Q-Pulse
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The Company
Dublin , Dublin
1,297 Employees

What We Do

Uniphar is a diversified healthcare services organisation with activities in Ireland, UK, Europe, the USA and APAC

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