Industrial.

QA Pharmacist (Band 6).

  • Regional Pharmaceutical Quality Assurance Service (RPQAS) Plenum Building, Royal Victoria Hospital
  • £16.52

QA Pharmacist (Band 6)

  • Regional Pharmaceutical Quality Assurance Service (RPQAS) Plenum Building, Royal Victoria Hospital
  • £16.52
  • Posted January 23, 2023

Job

The person appointed will work as part of a team and will have
delegated responsibility for designated aspects of the Regional
Pharmaceutical Quality Assurance Service. This service is
concerned with the quality of medicinal products and other
associated items used by the hospital pharmaceutical service
whether obtained from commercial sources, prepared in pharmacy
departments, or manufactured in pharmaceutical production units. It
ensures a high standard by providing a system of tests, audits and
controls. He/She will be based at the Regional Pharmaceutical
Quality Assurance Service in the Plenum Building, Royal Victoria
Hospital. The regional production unit, Victoria Pharmaceuticals is
also housed in the Plenum Building.
The post holder may have other duties that will take him/her to other
sites including Victoria Pharmaceuticals at Knockbracken.
The following standards and publications provide the basis on which
the service is developed and maintained, in addition to
pharmaceutical legislation.
a) Rules and Guidance for Pharmaceutical Manufacturers
and Distributors 2015, MHRA.
b) Aseptic Dispensing for NHS Patients, Department of Health,
1995.
c) Aseptic Dispensing in HPSS Hospitals HSSE (OCE)1/97.
d) The Quality Assurance of Aseptic Preparation Services,
Beaney AM (ed) 5 th Edition.
e) HPSS Medicines Management Standard (Safe and Secure
Handling of Medicines), current version.
f) A Spoonful of Sugar – Medicines Management in NHS
Hospitals. Audit Commission, 2001.
g) National Guidance on the Safe Administration of Intrathecal
Chemotherapy [HSS(MD)45/2003]
h) Pharmaceutical Isolators, edited by Midcalf, Phillips, Neiger
and Coles, The Pharmaceutical Press 2004.

 

PRINCIPAL DUTIES

1. To assess microbiological environmental data to determine compliance of
unlicensed aseptic and licensed manufacturing units with relevant standards. To
implement corrective actions as necessary.
2. To act as a releasing officer for overlabelled and pack down products by the
Regional NHS Manufacturing Unit (Victoria Pharmaceuticals, Royal Hospitals).
3. To participate in the investigation and reporting of defective pharmaceutical and
medical and surgical products in accordance with relevant national, regional and
local procedures.
4. To assist in the risk assessments of unlicensed medicinal products.
5. To assist in developing analytical methods to determine the quality and stability
of finished products, dispensed medicines in various dosage forms and raw
materials.
6. To assess the analytical and microbiological tests carried out by RPQAS on raw
materials, packaging components, consumables and finished products including
IMPs for clinical trials to ensure their suitability for use.
7. To assist in maintaining the PQS for all VPs MHRA licences.
8. To assist in the integration of the Validation Master Plan for Victoria
Pharmaceuticals.
9. To assist in the response to internal audits and regulatory inspection
findings/deficiencies and ensure agreed action plans are completed in a timely
manner.
10. To participate in the training of pharmacists, technical staff, pre-registration
pharmacists and other healthcare staff in quality assurance and quality control
issues.
11. To act as a member of a team to set priorities and plan objectives for the service.
To develop and maintain high professional standards and procedures which
ensure safe systems of work.
12. To develop the service to meet any changing need.
13. To assist in the clinical trials production service in Victoria Pharmaceuticals (VP)
as and when deemed necessary by the Regional Quality Assurance Pharmacist
and the VP Production Manager, supported by clear lines of responsibility.
14. To contribute to the maintenance and development of SOPs and departmental
documentation according to current GMP standards and assist colleagues in
other areas of hospital pharmacy in this respect.
15. To act as a member of a team to set priorities and plan objectives for the service.
To develop and maintain high professional standards and procedures which
ensure safe systems of work.
16. To develop the service to meet any changing need.
17. To participate in practice research and development in the field of
pharmaceutical quality assurance.
18. To establish and maintain interpersonal relationships with other healthcare staff.

 

ESSENTIAL CRITERIA
1. M.Pharm. or equivalent.
2. Be a member of the Pharmaceutical Society of Northern Ireland or eligible for
membership
3. Have an understanding of legislation and guidance relevant to GMP.
4. Ability to motivate self and others.
5. Evidence of team working and building working relationships.
6. Have effective communication skills, both oral and written which will meet needs of
the post in full.

Apply for this job.

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