Chargé(e) Assurance Qualité Opérationnelle - MES, Gidy

Date de parution:

16 nov. 2025 Ville:

GIDY Pays/Région:

FR Type de contrat:

CDI N° offre:

9394 M.E.S. Quality Business Expert (H/F)

Challenges As an MES Quality Business Expert, the role involves supporting the MES program by collaborating with various stakeholders, reporting activities, ensuring GMP compliance, participating in workshops, testing, change management, training, commissioning, and providing hyper care assistance to facilitate the deployment of MES at pharmaceutical and chemical sites.

Main responsibilities of the Quality Assurance Manager

Ensure the implementation of the company's Quality Policy and compliance with current rules or guidelines

Stay informed of all regulatory changes or national and/or international guidelines related to activities within their scope and propose appropriate measures

Assist relevant employees in implementing the quality policy and quality documents

Identify regulations/guidelines applicable to the activity

Provide advice and support when necessary

Coordinate the creation and/or revision of quality documents according to the approved quality plan

Ensure compliance with quality documents

Participate in training on regulations, applicable guidelines, and quality documents for employees

Implement and monitor the quality risk prevention strategy for the projects under their responsibility

Monitor quality indicators to assess the effectiveness of the quality management system

Participate in supplier evaluations and conduct on-site Good Practices (BPx) audits within their area of expertise

Main responsibilities of the MES Quality Business Expert

As an MES quality business expert with operational expertise and knowledge in quality, you will support the MES program by contributing to all activities necessary for the deployment of MES at various pharmaceutical and chemical sites.

Collaborative work: work with the MES Workstream Leader, all business experts of the team, solution managers (including those from other IT systems interfacing with MES) for all activities requiring the participation of the MES quality business expert.

With the Morphe’Us Quality Stream:

Report at least once a week on completed activities, pain points, needs for assistance…

Participate in the weekly Quality meeting

Ensure the link between the two streams (MES and Quality)

Consult the Quality stream when necessary

Before or in parallel with the detailed design phase, work closely with the BMR Simplification Manager, responsible for simplifying, harmonizing, and standardizing batch manufacturing and packaging records (BMR and BPR). To do this, you will need to:

Act as a quality expert (SME) to ensure compliance with GMP while challenging overly complex processes and proposing simplifications

Actively participate in workshops and field discussions to gather information, identify quality pain points, and propose improvements

Prepare arguments and justifications to support simplification decisions, in accordance with GMP

Collaborate to document decisions, justifications, and best practices to support consistent deployment and integration across different sites and establish guidelines

Be the quality spokesperson for this working group, to promote simplification choices across quality manufacturing quality sites

Detailed design:

Prepare all necessary information for a workshop where MES quality activities and concerns are discussed

Actively participate in workshops

Review workshop topics

Translate operational and quality requirements into MES-compatible MBR structure

Testing Phase

Participate in the definition of tests to be performed during ITC/UAT

Review tests performed during development

Perform / Participate in UAT tests and report defects when necessary

Change management:

Participate in identifying impacts on the Quality team and support site Quality teams in adopting new working methods

Facilitate dialogue between QA and Manufacturing teams (Morphe'Us project and site teams)

Define and monitor, with the Quality stream and site Quality team, the action plan

Promote a risk-based, value-driven approach to the design of quality processes within the MES framework

Training

Participate in the definition of the training plan for key users (KU) and end users

Validate training materials when quality activities are described

Assist or carry out the training of key users (KU)

Go-live (site by site)

Participate in the definition of all activities required prior to commissioning (transition activities)

Assist key quality users in carrying out activities

Hyper care:

Assist quality key users during the hyper care period

Be a facilitator during the first weeks of activity

Participate in defect management during this period

Profile required Training and Professional Experience:

Pharmacist or graduate from an engineering school, Master's degree level or equivalent experience (at least 5 years)

Experience in cross-functional projects or MES implementation is a plus

Technical Skills:

Solid experience in quality assurance in pharmaceutical or chemical manufacturing

Good understanding of batch master records (paper or digital) and GMP constraints

Managerial Experience:

Comfortable working in collaborative and multi-site environments

Ability to challenge the status quo while respecting compliance requirements

Personal Skills:

Excellent interpersonal, facilitation, and communication skills

Languages:

Bilingual in English (reading, writing, speaking), French is a plus

Location:

Gidy (ORLEANS), with travel within France (Paris, Bolbec) and internationally (Ireland, Spain, Poland)

Nous sommes engagés pour l’égalité des chances et le développement des talents dans toute leur diversité. Nous accordons autant de valeur à l’expérience qu’à l’envie de s’engager au quotidien pour être utile au progrès thérapeutique au bénéfice des patients. Si vous vous reconnaissez dans cette offre et ces quelques lignes, saisissez cette opportunité de nous rencontrer.

#J-18808-Ljbffr