Description de fonction

Reporting to the Quality Assurance Director, you are responsible for a QA team. Your role is to guarantee the
conformity of the quality system and the products and to manage the activities of the QA department, by
coordinating the team and the budget of the department.
You establish and implement the quality management system and accompanying procedures, in accordance with
cGMP standards, customer standards, legal standards and patient safety. You will contribute to your mission
through the following actions:

Guarantee the health of the end user: enforce regulatory guidelines.
Write / revise the quality assurance procedures according to the evolution of the requirements of
the health authorities and the requirements of the customers:
• Approve all site quality procedures.
• Approve qualification and validation activities.
• Coordinate investigations relating to deviations and quality issues.
• Evaluate the impact of all changes and deviations.
• Undertake the necessary corrective actions in the event of deviations: coordinate the project team.
• Contribute to the implementation of CAPA actions.Ensure batch release, based on all production and analytical documentation, in accordance with
regulatory requirements and within the deadlines required by customersBe the main contact person for regulatory inspections and customer audits (organization, follow-up,
etc.)Develop the "Quality" spirit through the organization:
• Sensitization of all staff
• Provide quality and cGMP training for all departments
• Organize and participate in internal audits
• Ensure that product quality reviews are written in accordance with regulatory requirements and on timePrepare the department's annual budget forecasting exercise and participate in periodic reviews
organized at the site level with precise figures and proposals.Support and grow the QA team
• Be a technical support for your team
• Increase the skills of your team

Profil recherché

Profil
Master in science (Chemical, Bio-Engineer, ..) or equivalent by experience 5 to 7 years experience, preferably in
different fields, as there are chemical (analytical, organic,..) technical, mechanical, organizational, information
flow.
Able to oversee all processes in and outside the company (Helicopter view)
Your experience has allowed you to have a good command of quality tools, GMP, and international guidelines.
Fluency in French and English in a professional environment is essential to be successful in this position.
You have good interpersonal skills, you are autonomous, rigorous and meticulous.
You have a sense of responsibility as well as a genuine interest in the pharmaceutical chemical industry sector.
The taste for collaborative work is essential.
It is your professional qualities as much as your interpersonal skills and your ability to transmit that will be your
best assets to evolve in this function!

Informations complémentaires

Localisation de l'offre d'emploi: 6534
Contrat Offert: CDI
Expérience requise: 2 - 5 ans exp.
Diplôme requis: Master

Contact - Postuler

Augea | | laure.mariscal@augea.be |

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