Quality Manager
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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.
Supervise Commercial and Contract Management
Use Capgemini Methods, Techniques and establish governance
Control contract & scope
Propose and discuss change requests
Push accurate billing/On time payments
Quality & Customer Support Manager and Investigation laboratory Manager at Sartorius Stedim- Bioprocess Solutions and Medical Device manufacturing
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
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