University Hospitals Birmingham NHS Foundation Trust
Band 4 Quality Assurance Associate - Logistics
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Job Summary
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 and supporting the QA Manager in day-to-day GDP activities.
Main Duties, Tasks & Skills Required
- Triage and quality review quality documents such as deviations, complaints, CAPAs, Change Controls.
- Ensure data integrity principles ALCOA+ are being followed within warehouse operations.
- Assist with the management and maintenance of the Quality Management System.
- Support QA manager in training i.e. GDP training, Falsified medicines training, deviation training, MHRA licence training, Controlled Drug training etc.
- Support the QA Manager in readiness for regulatory inspections (MHRA, Home Office etc).
- Assist in root cause analysis when investigating complaints and deviations.
- 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.
- 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.
- Be the first point of contact to the warehouse operations for quality related issues regarding medicinal product and/or GDP activities.
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About Us
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.
Job Description
Please Note : For a detailed job description for this vacancy, please see attached Job Description
Person Specification
Qualifications
Essential
- Life Science Graduate or equivalent.
- A Level science or equivalent.
Experience
Essential
- Experience and knowledge/understanding in GDP & GMP (Good Manufacturing/Distribution Practice).
- Experience working in a pharmaceutical environment.
- An understanding of maintaining a Quality Management System.
Desirable
- Knowledge of GDP is desirable; however, training will be given.
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Additional Criteria
Essential
- Flexibility with working hours if required to support the service.
- Enthusiastic, reliable and trustworthy and displays a mature attitude.
- Demonstrates ability to work to set procedures.
- Careful and accurate in work.
- Able to demonstrate discretion and diplomacy.
- Good team player and able to motivate others.
- Demonstrates ability to work independently, if required.
- Keen to develop own person skill and use these for the benefit of others.
- Able to communicate at an appropriate level complex information verbally, written and electronically as required.
Required
- Able to adapt to change.
- Ability to travel across all Trust sites; however, the main base will be Kings Norton Melchett Road.
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
For Help With Your Application, Contact
Piush Champaneri
01214243914
Pay scheme
Agenda for Change
Band
Band 4
Salary
£28392.00 to £31157.00 Yearly
Contract
Fixed Term
Duration
12 Month(s)
Working pattern
Full-Time, Flexible Working
Reference number
304-1101206
Job locations
32-34 Melchett Rd
32 - 34 Melchett Road
Kings Norton
West Midlands
B30 3HY
Attachments
[Job Description](Band 4 Quality Assurance Associate JD PS.pdf – 342KB) Opens in a new window
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