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Regulatory Affairs Manager

Missions

Perform all activities related to the registration and maintenance of Active Substance Master Files (ASMFs) according to the European Drug Master File (EDMF) procedure, or DMF files (type II) with the US-FDA, in compliance with regulations. For this, you will have to:

- provide advice and assistance on regulatory aspects for the relevant departments (development, production, quality, sales, etc.), to respond to requests for expertise or documentation,

- propose regulatory strategies and coordinate the establishment of ASMF or DMF files, and, if necessary, participate in writing sections to assist the departments,

- write variation files, or files to respond to questions from European and international health authorities, and collect the necessary supplements for active pharmaceutical ingredients,

- participate in the continuous monitoring of regulations and standards, nationally and internationally, for the planning of regulatory affairs activities

- manage the DMFs and ASMF with authorities and customers

Contract type: temporary / permanent Location : Courville sur Eure

Who are you?

With a science education, you have gained significant experience in the pharmaceutical world where you were able to approach the management of pharmaceutical materials

You are a Pharmacist or you have a Master of Regulatory Affairs, and you have 2-3 years experience in regulatory affairs.

Communication and organization skills, independence and rigor will be major assets to succeed in this function.

A fluent level of English (oral and written) is required for this position.

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Quality Assurance Technician

Missions

Implement the quality system (procedures, indicators, audits, training, etc.) in the production activities of the active pharmaceutical ingredients. For this, you will have to:

- coordinate the development of quality assurance tools (procedures, checklists, information materials)

- write quality procedures

- monitor the implementation of procedures and regulations concerning quality

- participate in audits of the quality of systems (suppliers / contractors, facility, etc.)

- organize and plan quality audits depending on the different services concerned

- monitor the implementation of preventive or corrective quality measures

- control and operate quality audits

- control the indicators of the quality dashboards

- propose quality management improvements and update the quality systems and tools

- educate and train the departments

- respond to internal and external questions about quality

Contract type: temporary / permanent Location : Courville sur Eure

Who are you?

With two to three years of post-secondary education in science, you have had an initial significant experience in production or quality, ideally in the active ingredients manufacturing sector.

You are independent and rigorous and have good interpersonal skills.

A fluent level of English (oral and written) is an asset for this position.

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Head of production team

Missions

Placed under the authority of the production manager, your role will be to ensure the operational management of a production team and the management of chemical facilities. For this, your duties will be divided into the following areas:

- operational coordination of the team (3-4 operators)

- assist with the management of the facilities

- inventory management

- guarantee respect for quality, safety, and the proper implementation of Good Manufacturing Practices

- ensure the site’s performance is in compliance in terms of cost / quality / time

Contract type: temporary / permanent Location : Courville sur Eure

Who are you?

With two years of post-secondary education in Process Engineering - Chemical Engineering or Chemistry, you have proven significant experience (minimum 2 years) in a similar position as a team leader in a chemical manufacturing unit.

The candidate will be recognized for his or her managerial and interpersonal skills.

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