Quality Specialist

The Quality Specialist is an integral member of the Quality Team, dealing with GMDP 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:

• Management of Quality management system including CAPA, Deviation, Change Control, risk assessments, Root cause analysis.
• Assist with self-inspections, regulatory and customer inspections.
• Handle returns of medicinal products.
• Management of product recalls.
• Temperature/Humidity data review for Uniphar UK storage facility.
• Investigate and perform impact assessment for temperature excursions for Uniphar UK storage facility and for excursions observed during product shipments.
• To perform quality assessment for the incoming imported shipments before placing the delivered stock into saleable.
• Prepare the RPi check ready for RPi release activity.
• 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.
• Dealing with product quality complaints-operation.
• Assist on quality queries to various departments.
• Respond to technical queries.
• Manage returns process.
• Provide product scans to DPL to generate product over label, label design form and product specification file for UK ‘specials’.
• Issue Batch Packaging Records (BPR) to production department in response to the work order requisition received from production department.
• To perform required Quality checks during over labelling run as per internal procedure.
• To perform Pre-QC checks on the completed BPR document by production after over labelling run and get it ready for final QC release.
• To perform QC check and release on incoming packaging material.
• Issuance of area/ and equipment usage logbooks.
• Retention sample management.
• Other duties as instructed by the RP / QC / 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 GMDP quality assurance in pharma industry.
• Proven experience of working with unlicensed medicinal products and Guidance Note 14.
• Experience in QMS, handling CAPA, deviations, risk assessments.
• Experienced in Internal auditing of GMDP Quality Systems.
• 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 secondary packaging, storage and distribution of pharmaceuticals under GDP and GMP.

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.