This contract is a framework agreement for Life Sciences support services. The consultant entering the IRE through this means may be a freelancer or a collaborator on the payroll of the successful bidder. It cannot be temporary.

The objectives of the missions are to provide human resources and expertise in the different aspects of pharmaceutical product production in a GMP environment and in particular:

- for the experimental and industrial development phases

- to set up quality systems and ad hoc documentation related to the pharmaceutical regulatory framework (qualification, validation, submission of dossiers to the competent authorities).

- to ensure the operation or improvement of production processes and equipment and the Supply Chain (production engineer, supervisors etc ...)

The contract is divided into lots as follows:

Lot 1: "P... (see contract documents)

Researcher profile:

• Main activities:

o Develop the production process of a radiopharmaceutical radioactive substance, from laboratory prototyping to regular production

o Ensure the sustainability of the raw materials supply network

o Develop the product taking into account the industrial constraints of production

o Develop the production process that guarantees customers the most adequate product quality

o Develop analytical quality control methods associated with the product

o Transfer the analysis methods to the Quality Control department

o Participate in the drafting of files allowing the commissioning of the process (nuclear and pharmaceutical safety aspects)

Laboratory Technician Profile

• Main activities:

o Carrying out laboratory tests in order to develop new production processes or improve production conditions

o Handling of radioactive solutions

o Sample preparation

o Use of various analytical devices (pHmetry, colorimetry, nuclear measurements, metal dosing etc ...)

o Maintain, control and calibrate equipment according to current procedures

Quality Assurance Support Profile

Background: Experience >3 years in Quality Assurance in the pharmaceutical & GMP sector

Main activities:

- Develop, improve and monitor quality systems such as the writing of product quality reviews, deviations, change controls, training, document management.

- Risk analysis writing

- Support for Regulatory Affairs (drafting of CTDs, DMF, ASMF and AMM and associated variations) and Pharmacovigilance.

- Support for qualification activities (analytical equipment, production equipment, computer software) and validations (analytical methods, manufacturing processes, cleaning): Drafting of URS, protocols and reports

Production supervisor / process engineer profile

• Background: experience of min. 3 to 5 years in a production environment (Pharmaceutical / Chemistry / BioTech ...)

• Main activities:

o Ensure the organization, planning and supervision of production operations

o Ensure investigations following anomalies

o Ensure the improvement of production processes and Supply Chain (including projects such as the introduction of new suppliers, etc ...)

o Coordinate or participate in projects for the replacement or installation of new production equipment