Badra Mrabet

Serious, dynamic, diplomate, passionate, positive and organized.

I like teamwork that takes place according to schedules and around clearly defined objectives.

I am always looking to improve and see in every change an opportunity to evaluate.

Communication, organization and planning are my best assets.

Professional experiencesMain tasksAdvanced Consultant-Capgemini ingineering:

2020 – Takeda -- Data integrity Consultant

Evaluation of manufacturing equipment data integrity and conduction according to Takeda applicable procedure assessments to several equipment as spectrophotometers, HVAC, palltronics, etc..

2021 – Takeda -- Raw materiem &Incoming good inspection Coordinator :

Support Receiving and Inspection activities of raw materials in order to ensure the product quality and the compliance to GMP, SOP’s, specifications and regulations.

Treatment and finalization of aging deviations and CAPAs

Assessment Change control and supplier notification impact on the receiving and inspection proces

2022- JnJ – Project, transition & transformation & risk management PQR/CPV and Doc management- CurrentlyWeekly catch up meeting with JnJ for operational update

Oversight over back office (Portugal & Morocco platforms) delivery pipeline

Identification and follow up of actions to resolve pain points affecting service performance and value 

Managing blocking points for the Capgemini Eng. back office, including :

-Centralizing and following up on access requests

-Following up on IT issues raised by Capgemini back office users 

-Following up on issues/pain points raised by back office team to ensure prompt resolution

-KPI follow up; RFT, OTD, approval on time, etc…

-Support for operational meetings & communication (JnJ sites with Capgemini Eng. back office)

-Operational meetings with JnJ site SPOC and Back office (workload vs. platform capacity/ hot topics)

-ADM4 transformation (operational way of working harmonization)

-Automation tool: Hands-on time efficiency gain data analysis

-JIRA tool: follow up with back office team on implementation

Monthly KPI extraction and consolidation with JnJ SPOC’s

Bi monthly APR approval report provided to JnJ Sponsor

Back office training completion follow Up

Steering committee preparation, presentation and action plan follow up.

Delivery and contract Management

Supervise Commercial and Contract Management

Use Capgemini Methods, Techniques and establish governance

Control contract & scope

Manage Client Expectations 

Extend client relationships

Propose and discuss change requests 

Spot opportunities/Delivery Led sales

Manage finances

Manage Contribution Margin

Manage finance KpIs

Push accurate billing/On time payments

Manage project reviews

Develop team members

Quality & Customer Support Manager and Investigation laboratory Manager at Sartorius Stedim- Bioprocess Solutions and Medical Device manufacturing

Since 02/01/2015

Representation of the quality policy and execution of the quality strategy with customersManagement of customer complaints from their openings until their closure Conduct quality indicators and conduct quality dashboards relating to customer complaints and feedback.Coordination of site audits; responsibility includes planning, preparation, training, supervision of external auditors and definition of action plans and follow-up of responses as well as audit indicators on the site.Definition and Implementing CAPAs and Effectiveness follow up and conduct CAPA indicatorsTeam management, training and developmentConduct activities ("crisis cell") related to customer; Ex: Risk analysis, quality crisis, materovigilance, product recall, contribution to "for cause" audits, etc.Provides GMP/BPD training to all employees of the site.

Provides Investigations, Root cause analysis, CAPA and technical writings.

Contributes to compliance with the rules of Quality, Health, Safety and Environment, respecting the quality, hygiene, safety and environmental guidelines and by detecting anomalies, potential quality incidents or accident risks Security EnvironmentQuality Assurance Specialist in a pharmaceutical industry -INFOMED PHARMA

2013-2015

Batch records review, investigation of quality events and CAPA implementation.Documentation managementContributes to compliance with the rules of Quality, Health, Safety and Environment, respecting the quality, hygiene, safety and environmental guidelines and by detecting anomalies, potential quality incidents or accident risks Security Environment Education

• Master degree in Quality Assurance -Institut Supérieur de Biotechnologie de Monastir.

• License degree in Medical Biotechnology-Institut Supérieur de Biotechnologie de Monastir.

Main Training

• Certified Trainer for investigations, Root cause analysis, CAPA and technical writings (Certified in New York with PathWise, FDA accredited organization)

• Certified internal auditor for ISO 9001 & ISO 13485

----------------------- Skills

• Microsoft office, Paint, Qualipro, Citrix, Trackwise, SAP, MS project.
• Optimization of production lines
• ISO 9001, ISO 13485, ISO18001, ISO14001
• HACCP
• Lean manufacturing, 5S, 8D.
• Project management,
• Analysis technique (Microscope numerique, integrity testing.) and investigation tools (5M, IS/IS NOT...)