Quality Assurance Manager (M/F) - Permanent Contract

仕事内容

MINAKEM, filiale du Groupe Minafin (900 pers - CA : 240 MEUR), accompagne, chaque jour, les plus grands acteurs du marché, dans leurs projets, pour améliorer la qualité de vie dans le monde.
Qualité, flexibilité, innovation sont nos maîtres mots.
Fort de nos implantations Recherche - Développement et industrielles en Europe et aux Etats Unis, nous proposons un panel de services et de produits diversifiés allant du sur mesure, building blocks, principes actifs génériques et brevetés aux produits intermédiaires de synthèse.

Jop purpose :
Our highly potent facility. The site is Located in the heart of Belgium, 20 km South of Brussels, in the Scientific Park bounded to the University of Louvain-La-Neuve.

Minakem High Potent (MHP) is a recognized world leader custom development and manufacturer of Highly Potent APIs (HAPI) requiring production under high containment systems down to OEB class 6, OEL < 0.1µg / m3 / shift.

Key Accountabilities :
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.

- Prepare 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
- 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 customers
- Be 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 time


Education and Experience :

Master in science (Chemical, Bio-Engineer, ..) or equivalent by experience 7 to 10 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.

Ref : 7802300