QA Officer

Who we are

Uniphar Group is a rapidly expanding diversified healthcare services business with a global footprint and a proud heritage in Ireland. Since Uniphar became a publicly listed company in 2019, the Group has grown organically and through a series of strategic acquisitions, which continue to strengthen Uniphar's international reach.

Culture at Uniphar

We pride ourselves in being truly entrepreneurial, innovative, collaborative, with a strong problem-solving ethos. We have built working relationships which span decades with many of the world's largest Pharma and MedTech companies. We believe that this is because we know how to build a relationship of trust with our partners - we put our customers and their patients at the heart of what we do and treat them with integrity and respect. Everything Uniphar does is enabled by our people. As we continue to grow domestically and internationally, we become more diverse. This rich diversity fuels our business and enriches our culture.

Objective:
The Quality Officer is an integral member of the Quality Team, dealing with aspects of Good Distribution Practice including quality management system, vendor management, Import and Export, Medicines, Medical Devices and other Healthcare Industry products. Work varies greatly from day to day and, once full training is given, the incumbent will be expected to organize their workload continuously, with guidance from the Team Leader.

Essential:

• Proven experience of working within quality assurance in pharma industry
• Experience in QMS, handling change controls, CAPA, deviations, risk assessments.
• Knowledge and understanding of Unlicensed Medicines regulations.
• Experience in performing technical checks on unlicensed medicines.
• Experience handling complaints, recalls, MHRA alerts and notifications.
• Essential computerised system skills e.g., Microsoft Office.
• 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 and within the team.

Desirable:

• Knowledge and understanding of storage and distribution of pharmaceuticals under GDP.
• Knowledge and understanding of regulatory requirement (MHRA)
• Knowledge and Experience of working with Controlled Drugs (Home Office license)
• Experience of using Q-pulse.

Main duties and Responsibilities:

• 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.
• Investigate temperature excursions.
• Creating / updating Standard Operating Procedures and work instructions.
• Completing drug and license applications for import and export of drugs (Home Office)
• CD license endorsements
• Customer complaints investigation and closure
• Dealing with product quality complaints
• Assist on quality functions to various departments.
• Trending and monitoring activities within the departments.
• Reviewing documents for unlicensed medicines.
• Request for permissions to supply unlicensed medicines.
• Submission of NHS quarterly report.
• Lease with translation service providers for the review of translation of product information leaflets and SPC's
• Respond to technical queries.
• Act as primary point of quality contact for unlicensed medicines queries.
• Manage returns process.
• Other duties as instructed by the Quality Team Leader/Head of Quality & Compliance.