Band 4 Quality Assurance Associate - Logistics

The individual will be working to MHRA Good Distribution Practice (GDP as per the

Human Medicines Regulation 2012/1916.

Assures consistent quality of storage and distribution of medicines by developing and

enforcing Good Distribution Practice (GDP), including maintaining the Quality

Management System, providing and administering suitable documentation; monitoring

all Quality processes including but not limited to Deviations, Change Control, CAPA and

Complaints ad supporting the QA Manager in day-to-day GDP activities.

Main duties of the job

Triage and quality review quality documents such as deviations, complaints, CAPAs, Change Controls.

To ensure data integrity principles ALCOA+ are being following within warehouse operations,

To assist with the management and maintenance of the Quality Management System.

To support QA manager in training. i.e GDP training, Falsified medicines training, deviation training, MHRA licence training, Controlled Drug training etc.

To support the QA Manager in readiness for regulatory inspections (MHRA, Home Office etc),

Assist in root cause analysis when investigating complaints and deviations.

To ensure queries raised at goods in are dealt with and give disposition to Goods in team and responsible for maintaining the goods in tracker.

Responsible for maintaining the recall tracker and supporting the RP with coordinating recalls,

To ensure unlicensed medicines are quality reviewed.

Review, verify and assign disposition regarding product activities or documents connected to the warehouse as appropriate.

Deal with QA enquiries promptly with due diligence.

To be the first point of contact to the warehouse operations for quality related issues regarding medicinal product and/ or GDP activities

University Hospitals Birmingham NHS Foundation Trust strives to have an inclusive culture where everyone feels like they belong, can thrive, knows that they add value and feels valued. We do this by developing compassionate and culturally competent leaders, being values driven in all that we do and by creating a welcoming and inclusive workplace that thrives on the diversity of our people. As such we want to attract and recruit talented individuals from all backgrounds, and for each of you to feel supported for the diversity you bring, to achieve your full potential. For those staff with a disability, including physical disability, long term health condition, mental health or neurodiverse condition, this also means being committed to making reasonable adjustments needed for you to carry out your role.