Qualified Person

2 weeks ago

NewcastleunderLyme, United Kingdom Alliance Medical Full time

**About the role**:
We have an exciting opportunity for a Qualified Person to join us at Alliance Medical. This is a full time role working 40 hours a week on a permanent basis.

We are ideally looking for an experienced Qualified Person, with management experience and responsbility for a Quality Management System. It is preferable that you have experience as a releasing QP within Radiopharmaceuticals/ steriles on a UK MHRA licence.

This role covers batch release of Radiopharmaceuticals for use in diagnostic PET scanning and contributing to the management of QMS.
- Working at Keele RPU predominantly but will support release at other sites occasionally._

**Duties & Responsibilities**:
**General Responsibilities**
- To undertake the duties of Qualified Person as specified in Article 51 of Directive 2001/83/EEC.
- To ensure AMR compliance with the requirements of Good manufacturing Practice.
- Contribute to the company quality assurance functions.
- Maintain independence from Operational personnel within AMR. - _see Organisation Chart._

**Specific Responsibilities**
- To review and evaluate batch records and authorise batch disposition (Annex 16 GMP Regulations).
- To ensure that testing is carried out, according to AMR analytical control procedures and EU Pharmacopoeia specifications
- To approve process deviations / laboratory investigation ensuring that problems are addressed in compliance with GMP and AMR procedures.
- To monitor the nature, extent and frequency of complaints
- To co-ordinate AMR recall procedure.
- To ensure appropriate ‘analytical method’ validation is carried out for all non compendial test methods.
- To support site validation activities ensuring that regulatory requirements are met.
- To approve AMR’s Change Control procedures.
- To co-ordinate AMR internal and external auditing programmes.
- To monitor performance of suppliers, contract laboratories and contract manufacturers (where applicable).

**Safety**
- To participate in AMR Safety Committee meetings.
- Responsible for following agreed safety procedures to ensure safety of yourself and others.

**Training**
- to review GMP and GLP training plans prepared for AMR personnel and contracted service personnel (maintenance and cleaning) as appropriate.

**Minimum Qualification**:
Third level qualification in a scientific discipline - pharmacy, medicine, chemistry, pharmaceutical chemistry and biology. In addition, must have fulfilled the education requirements for the role of the Qualified Person such as a diploma in Pharmaceutical Manufacturing Technology.

**Previous Experience**:
Minimum 3 years practical experience in activities of quantitative and qualitative analyses of active substances and of the necessary testing and checking to ensure the quality of medicinal products.

**Behavioural Competence**:

- Customer Focus: Good communication skills (verbal and written). Able to obtain information from customers to deliver the requirements of the role. Works to deliver best service to customers and manage their expectations.
- Teamwork: Can work well in a multi-disciplinary team and across teams to deliver requirements of role.
- Quality and Safety: Understands the quality standards required for the role and supports continuous improvement. Able to manage own performance to deliver on agreed objectives.

Flexibility: Able to adapt to meet the needs of the business at any point in time, as a result of Exposure to a wide variety of

**Alliance Medical Values**:
About Alliance Medical

Alliance Medical are Europe’s leading independent provider of imaging services.

We combine service excellence and innovative imaging technologies to improve patient care and support NHS and independent organisations with their ongoing imaging requirements. Our approach has delivered consistent company growth for more than 30 years.

We live by our company values to ensure the highest level of patient care:
Our Values

Leaders, managers, and supervisors have a particular responsibility to be role models in terms of how they demonstrate these values themselves and how they engage their teams to work in this way.

**Collaboration**:
We work together and in partnership for all our patients. We respect expertise and combine it to achieve more.

**Excellence**:
We never compromise. We strive to deliver the very best in everything we do to ensure the highest quality of care. We treat our patients and each other with compassion, dignity and respect.

**Learning**:
Knowledge and understanding comes from learning. At Alliance Medical we are committed to ensuring that each and every one of us keeps on learning and that we continuously look for improved ways of working.

**Efficiency**:
Efficiency in healthcare means more patients get better care. We constantly seek new ways to use the scarce resource of healthcare more intelligently so that more people can live longer, fuller lives.

**Openness**:
We act with transparency and honesty in everything we d

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