Job Summary / Main Purpose

Manage and co-ordinate quality assurance activities in the BHSCT Radiopharmacy production facility ensuring that the service operates in compliance with relevant statutory legislation, standards and guidance. Collaborate with the Chief Radiopharmacist and production staff to ensure effective integration of quality requirements.

Main Duties / Responsibilities

For each of the following, the postholder will;

 Be responsible for the management and operation of the Pharmaceutical Quality System (PQS) in the BHSCT Radiopharmacy production facility, ensuring the service operates in line with relevant statutory legislation, standards and guidance.
 Lead on the investigation of quality deviations, identifying root causes and appropriate corrective and preventative actions. Contribute to, and peer review, investigations lead by other members of the quality and production teams.
 Contribute to the effective management of change though development, management and operation of the change control process.
 Contribute to the management of risk in the BHSCT Radiopharmacy through application of the principles of quality risk management.
 Provide expertise and advice on the Pharmaceutical quality requirements for introduction and supply of new radiopharmaceuticals from the BHSCT Radiopharmacy production facility.
 Be responsible for release of prepared radiopharmaceuticals as nominated pharmacist.
 Ensure that the PQS in the BHSCT Radiopharmacy is maintained and developed in accordance with the requirements of relevant licensing and regulatory authorities.

Be responsible for updating and enhancing the BHSCT Radiopharmacy production facility’s documentation in compliance with relevant statutory legislation, standards and guidance, ensuring that changes are managed and communicated in line with the unit’s quality management system.
 Ensure that all changes to the PQS are effectively communicated to all staff involved in the delivery of BHSCT radiopharmacy production service.
 Be responsible for reviewing all current practices, procedures and policies within the BHSCT Radiopharmacy production facility, ensuring they are fit for purpose and in compliance with current legislation, standards, guidance and Trust policies.
 Ensure that relevant documentation including the validation master plan are updated and maintained in compliance with current legislation, standards and guidance.
 Ensure awareness of quality exceptions and to ensure that satisfactory corrective and preventative action is taken.
 Contribute to the development and maintenance of a rolling programme of quality audit, ensuring that any issues identified are addressed through appropriate action and re-audit.
 Contribute to the preparation, hosting and follow-up for external audit and regulatory inspection.
 Maintain an active program of self-development and education including attendance at courses/scientific meetings where required.
 Ensure own work is compliant with relevant legislation (e.g. Good Manufacturing Practice (GMP), transport regulations) and local policy and procedures.

Qualifications
Registration
Experience

 An MPharm/BSc degree in Pharmacy.
 At least 5 years’ post-registration experience including:

i. At least 2 years’ hospital pharmacy experience at band 7 or above.

or

ii. At least 2 years’ experience in a quality assurance or GMP role.

 Membership of Pharmaceutical Society of Northern Ireland or eligible for membership.

 Have a diploma/MSc in Pharmaceutical Technology and Quality Assurance (PTQA) or equivalent or willing to commence this within two years’ of appointment.

 Experience and knowledge of aseptic/manufacture of sterile medicinal products.
Shortlisting by Application Form

 Good working understanding and application of regulatory requirements, including Good Manufacturing Practice (GMP) and pharmaceutical quality systems.

 Experience of developing and implementing pharmacy related policies and procedures.

Knowledge
Skills
Abilities

 In-depth knowledge of Good Manufacturing Practice (GMP) and other relevant regulations associated with manufacture and preparation of pharmaceutical/ radiopharmaceutical products.

 Highly developed interpersonal and communication skills with the ability to communicate effectively with a range of groups including pharmacy teams, engineers, clinicians, regulatory inspectors, customers and contractors.

 Demonstrable ability to initiate, implement, and manage service developments and changes.

 Demonstrable ability to identify and manage risk.

 Well-developed planning and organisational skills including the ability to prioritise service demands and to plan the workload of self and others.

 High level of demonstrable proficiency in the use of Microsoft Office suite of products including Excel and Word.

 Motivated, enthusiastic team worker but with ability to work independently.

 Able to give quick, reasoned, accurate guidance in stressful situations.

 Able to take responsibility where appropriate.

 Willing to work flexible hours to allow the service to be covered.