UK QMS Specialist
Full Time Permanent
The Role
The Quality Specialist is an integral member of the Quality Team, dealing with GDP aspects for pharmaceutical products, medical devices and other healthcare industry products. Work varies greatly from day to day, and the incumbent will be expected to organize their workload continuously, with guidance from leadership to ensure continuous improvement is driven
Key Outcomes
- Support the Quality Management Systems on Q-Pulse across all UK entities including Doncaster Pharma Ltd, Dial-a-Chemist UK and MedTech UK which operate under an ISO 13485, ISO 9001, GPhC, WDA(H) or MS license.
- Processing, review and approval of Quality records including, but not limited to, CAPA, Deviation, Change Control, risk assessments, Root cause analysis.
- Dealing with product quality complaints-operation
- Collate and send regular QMS Trends and updates to Business.
- Support the preparation of management review slides.
- Maintain approve suppliers, vendors and subcontractors in Q-Pulse
- Management of Quality Technical Agreements/SLAs
- Assist with self-inspections, regulatory and customer inspections.
- To track the CAPA progress for the Internal and External audits.
- Document archival and retention management.
- Creating / updating Standard Operating Procedures, Standard forms and work instructions.
- Customer complaints investigation and closure. Send official communication to the customer with outcome of the investigation.
- Assist on quality queries to various departments.
- Training management
- Other duties as instructed by the RP/ Quality & Compliance Lead/UK Head of Quality.
- 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.
- Proven experience of working with unlicensed medicinal products.
- Experience in QMS, handling CAPA, deviations, risk assessments.
- Experienced in Internal auditing of GxP Quality systems, including medical devices.
- Essential PC skills, including Microsoft Office, Excel, and Outlook.
- Ability to quickly adapt to the new processes and various IT systems.
- Excellent organizational skills.
- Excellent attention to detail.
- Good understanding of confidentiality.
- Adapt to working under pressure in a fast-paced environment.
- Ability to work independently.
- Knowledge and understanding of storage and distribution of pharmaceuticals under GxP and Medical Device legislation..
Desirable:
- Experience of using Q-pulse
- Internal Auditor certificate
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.
