Section one: Contracting authority
one.1) Name and addresses
Cardiff University
Procurement Services, The Spark Building, 3rd Floor, Maindy Road
Cardiff
CF24 4HQ
Telephone
+44 2920879648
Country
United Kingdom
NUTS code
UKL - Wales
Internet address(es)
Main address
http://www.cardiff.ac.uk/business/why-work-with-us/for-suppliers
Buyer's address
https://www.sell2wales.gov.wales/search/Search_AuthProfile.aspx?ID=AA0258
one.2) Information about joint procurement
The contract is awarded by a central purchasing body
one.3) Communication
Additional information can be obtained from the above-mentioned address
one.4) Type of the contracting authority
Body governed by public law
one.5) Main activity
Education
Section two: Object
two.1) Scope of the procurement
two.1.1) Title
Contractor for quality assurance for PETIC department
two.1.2) Main CPV code
- 72225000 - System quality assurance assessment and review services
two.1.3) Type of contract
Services
two.1.4) Short description
Following a regulatory inspection in November, PETIC is looking to source a temporary contractor to support quality assurance processes in PETIC for a period of 6 months in the first instance.
two.1.6) Information about lots
This contract is divided into lots: No
two.2) Description
two.2.2) Additional CPV code(s)
- 72225000 - System quality assurance assessment and review services
two.2.3) Place of performance
NUTS codes
- UKL22 - Cardiff and Vale of Glamorgan
two.2.4) Description of the procurement
PETIC requires QA support for managing workflows Documentation, quality trackers, Q-Pulse, completion and closure of paper and electronic records, as well as support for Supplier Management and executing self-inspections. In addition to these routine tasks, the contractor would need to assist with Quality Assessment of Deviations and Quality Events, assessment and approval of CAPA.
Potential contractors need to have experience of QA activities within a GMP Manufacturing environment, given PETIC’s very specific and niche product portfolio, we require someone with an understanding of aseptic/sterile manufacture, and it would be desirable for them to have experience of radiopharmaceuticals, and an appreciation of remediation activities.
two.3) Estimated date of publication of contract notice
14 March 2025
Section four. Procedure
four.1) Description
four.1.8) Information about the Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: Yes
Section six. Complementary information
six.3) Additional information
(WA Ref:148257)