Senior QA and Data Specialist
Full Time Permanent
The Role
This role involves ensuring compliance with MHRA regulations, support business GDP compliance, work closely with RPs and support other business functions with compliance requirements. Senior Quality and Data Specialist will play a critical role in managing the creation and maintenance of pharmaceutical items, understanding commodity codes, managing various types of pharmaceutical products, storage conditions and supplier/customers categories on the ERP system. Tasks will 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
- Oversee the creation of new pharmaceutical products in Uniphar UKs ERP system in compliance with MHRA
- Manage data cleanse in the business ERP system
- Manage customer types, remove duplicates and monitor annual bona fide checks
- Manage supplier annual bona fide checks and place suppliers on hold
- Work closely with Business Units & Project teams to ensure optimum Master Data quality & efficiency
- Proactively highlight any issues around Master Data quality, compliance & governance
- Understand and apply commodity codes for pharmaceutical products
- Ensure accurate classification and documentation of products for customs and regulatory purposes
- Assist with the training of business units on Master Data processes (content, quality & governance).
- Review and approve UK pharmaceutical suppliers and customers qualification/requalification packs
- Review and approved non pharma worldwide suppliers and customers qualification/requalification packs
- Perform customer and supplier bona fide checks (EEA and non EEA)
- Support customer complaints, incidents, CAPAs and change management across the UK business entities
- Perform Risk Assessments
- Perform internal self-inspections
- Ensure business is GxP and ISO 9001 compliant
- Support process development and improvement
- Create RPi packs
- Stay updated on changes to pharmaceutical regulations and adapt practices accordingly
- 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:
- Previous experience supporting a WDA(H) QMS with the same licence conditions
- Proven experience of working within quality assurance in pharma industry
- Experience in QMS, handling change controls, CAPA, deviations, risk assessments.
- 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.
- 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 GDP.
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.
