- Country: Canada
- Summary: Professional Services for Quality Assurance (Qa) Consultant Clinical…
- CAT Ref No: 94052244
- Deadline: 15 Jan 2024
- Financier: Self Financed
- Purchaser Ownership: Government
- Tender Value: Refer Document
- Notice Type: Tender
- Document Ref. No.: 23-58170
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- Description:
- 2.BACKGROUND
The NRC is building a new permanent, GMP-compliant clinical trial material facility (CTMF) at its Royalmount Avenue site in Montréal. When complete, this facility will be used to manufacture vaccine and other biologic materials for clinical trials, to support vaccine development at the clinical trial stage.
As a member of the multidisciplinary project teams, the consultants specialized in Quality Assurance, actively participates in all stages of the implementation, validation and operationalization of the CTMF in compliance with applicable Health Canada, European and FDA regulations, internal policies and procedures.
3.OBJECTIVE(S)
The consultants will provide quality assurance support during the implementation, validation and operationalization of the CTMF
4.DESCRIPTION AND STATEMENT OF WORK, DELIVERABLES AND TIMELINES
Review and approve documents generated for the following processes:
1.Equipment and facility validation
2.Product tech transfer
3.GMP processes for facility operationalization and start-up such as:
3.1.Access Management
3.2.Alarm Management
3.3.Analytical Method validation
3.4.Batch Record
3.5.Batch release
3.6.Buffer/media prep
3.7.Clean Utilities
3.8.Material Cleaning (manual and part washer)
3.9.DSP (Downstream processes)
3.10.Filtration Validation
3.11.Incoming material release
3.12.Pest control
3.13.Preventive Maintenance / Calibration Program
3.14.QMS (Deviation, change con... - Documents:
rfp_23-58170_professional-service-qa-consultant_ctmfv3_incannex_sr_19dec.pdf
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CLICK HERE TO LOGINProfessional Services for Quality Assurance (Qa) Consultant Clinical… - Canada Tender
The NATIONAL RESEARCH COUNCIL CANADA, a Government sector organization in Canada, has announced a new tender for Professional Services for Quality Assurance (Qa) Consultant Clinical…. This tender is published on CanadaTenders under CAT Ref No: 94052244 and is categorized as a Tender. Interested and eligible suppliers are invited to participate by reviewing the tender documents and submitting their bids before the deadline on 2024-01-15.
The estimated tender value is Refer Document, and full details, including technical specifications and submission requirements, are provided in the official tender documents. Ensure all submissions meet the criteria outlined to be considered for evaluation.
