1.Creates Label Text in compliance with GCP and GMP regulations.
2.Ensures Change Requests are in place to enable packaging and labelling activities.
3.Manages the creation and approval of Product Specification File in collaboration with PM, Quality, Regulatory Affairs, Supply Chain.
4.Ensures clinical study vaccines are available in accordance with Supply chain.
5.Participates in Clinical Trial Team.
6.Contributes to the revision of trial specific documentation in meetings.
7.Ensures that vaccine products are released by QA functions.
8.Performs sponsor release of vaccines according to delegated authority from QP.
9.Coordinates shipments of vaccines to clinical sites, ensuring cold chain compliance and all import/exports documentation is in place if applicable.
10.Ensures deviations are handled in a timely manner with appropriate QC functions. Acts as owner/ investigator within the quality system when appropriate.
11.Initiates process within systems in accordance with the clinical trial budget and requirements. Ensure a quote proposal is accurate and covers the requirements of clinical trial.
12.Ensures PO numbers and Work Orders are created and approved prior to start of any activities with third party vendors. Responsible for invoices, tracking expenditure and monthly accruals.
13.Maintains GxP accountability documentation for all vaccine products.
14.Ensures participation at Investigator meetings and deliver training on CSV management