M.E.S. Quality Business Expert - Orléans - Servier Group

Description

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

1. Ensure the implementation of the company's Quality Policy and compliance with current rules or guidelines.
2. Stay informed of all regulatory changes or national and/or international guidelines related to activities within their scope and propose appropriate measures.
3. Assist relevant employees in implementing the quality policy and quality documents.
4. Identify regulations/guidelines applicable to the activity.
5. Provide advice and support when necessary.
6. Coordinate the creation and/or revision of quality documents according to the approved quality plan.
7. Ensure compliance with quality documents.
8. Participate in training on regulations, applicable guidelines, and quality documents for employees.
9. Implement and monitor the quality risk prevention strategy for the projects under their responsibility.
10. Monitor quality indicators to assess the effectiveness of the quality management system.
11. 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

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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).
9. 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.
10. 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).