Quality Assurance Officer

Zoek Pin Dinnington, Newcastle upon Tyne, England

Permanent (Full time)

Recently Posted

About This Role

We have an exciting opportunity for a Quality Assurance Officer to join our Dinnington team.

This is a full time role working 40 hours a week attracting a salary of between £35,000 - £43,000 (dependant on experience).

You will be a Scientific Graduate with a Scientific background and have previous experience of working in a in a pharmaceutical QA environment and Knowledge and/or experience of working within a Quality Management System is required.

Experience of (radio) pharmaceutical manufacture or Quality Control in a GMP environment would be advantageous.

Please note that we will be interviewing throughout the duration of this advert. Therefore if you are interested in this role an early application is advised as we may close the advert prior to the advertised date.

Quality Assurance Officer

Main Role

Undertake production of Fluorine-18 (18F) and radio-synthesis of 18F radiopharmaceuticals for PET imaging.

Duties & Responsibilities

General Scope of Role

• To work with the Site and other releasing QPs to administer the on-site Product Quality System.
• To act as the site Quality Assurance representative whilst working with the Site QP and Operations Manager.

General Responsibilities

To help ensure AMR compliance with the requirements of Good manufacturing Practice and Regulatory Rules and Guidelines.

Contribute to the company quality assurance functions.

Specific Responsibilities

Work with the releasing QP to ensure that batch records and other documentation is completed to the expected standards during the Batch Review and Release process

To ensure via the site QP that the Quality Management System is managed and maintained to the requirements and standards set down in Company Policies

To collate process deviations and laboratory investigations ensuring that problems are addressed in compliance with GMP and AMR procedures. To prepare information for the periodic Quality Management Meetings and track the performance against KPIs and the specified standards?

To monitor the nature, extent and frequency of complaints

To co-ordinate AMR recall/withdrawal procedure.

To support site validation activities ensuring that regulatory requirements are met.

To co-ordinate and carry out AMR internal site auditing programmes.

To act as an advisor to the site team in aspects of Quality and Continual Improvements.

To take part when required in site Inspections by Regulatory Authorities.

To help ensure that the RPU is Inspection ready at all times.

To support Continual Improvement where necessary as part of ongoing systems management.

To take part in the regular Quality Management Meeting

Safety

To participate in AMR Safety Committee meetings.

Training

In conjunction with the Site QP to review and prepare GMP and GLP training plans prepared for AMR personnel and contracted service personnel (maintenance and cleaning) as appropriate. To assist in provision of training against the agreed plan as appropriate.

Alliance Medical Values

Alliance Medical 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 do, where staff are encouraged to speak up to ensure a safe and secure environment for our patients.

Additional note

This Job Description is not inflexible, but is an outline and account of the main duties of the position. Any changes will be discussed with the job holder in advance. The Job Description will be reviewed periodically to take into account changes and/or developments in service requirements.!

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