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About the role

We have an exciting opportunity for a Qualified Person to join us at Alliance Medical. .

Batch release of Radiopharmaceuticals for use in diagnostic PET scanning and contributing to the management of QMS.

Working across both Sutton and Guildford RPUs predominantly but will support release at other sites occasionally.

Position can be located at either Sutton or Guildford, but time will be split roughly 50/50 at both sites.

This is a full time role working 40 hours a week on a permanent basis.

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.

Qualified Person

Experienced Qualified Person, with management experience and responsibility for a Quality Management System. It is preferable that the candidate has experience as a releasing QP within Radiopharmaceuticals and or sterile products and has been on a UK MHRA licence.

Duties & Responsibilities

General Responsibilities

• 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.

• To participate in training and assessment activities related to the position of QP.

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.

Job Dimensions - Direct/Indirect Reports and Financial Responsibility

People Management Responsibility: None.

Financial / Budgetary Responsibility:

Delegated authority: Purchase order authorisation up to £500.00 within agreed parameters. Ensure costs are minimised.

Decision Making Responsibility: Tactical low value decisions with escalation to Procurement Manager for service issues and decisions on financial commitment. Ensure administration is completed and updated in a timely manner and ensure administrative processes are reviewed for continuous improvement and efficiency.

Job Knowledge, Skills and Experience

• Minimum of 5 GCSE, Grade C or above, including English and Mathematics (or equivalent qualifications).
• Administrative experience in a professional / customer services environment.
• Experience of procurement practises including supplier negotiation – preferred but not essential
• Good IT skills, notably Word and Excel.

Experience within a procurement department is desirable but not essential

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

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.