Mes compétences :
Qualité
Pharmacie
Eau
Assurance Qualité
Conseil
Compliance
Entreprises
Famar
- Pharmaceutical Quality Assurance Engineer
Paris2014 - 2015Perform the QA review and approval of the following GMP documentation that has direct impact on the activities:
- Quality Investigations (Deviations, Anomalies)
- Standard Operating Procedures
Support the responsible pharmacist in the execution of QA processes including batch record review, product disposition and quality issue resolution to maintain the flow of products and documents to meet site objectives
Collaborate with other Quality professionals across the organization to ensure consistent application and execution of key quality systems
Maintain a high level of understanding of relevant production processes and quality systems
Collaborate with, and influence, other assigned area members to facilitate process improvements and risk assessments
Collaborate in data analysis on quality metrics and key performance indicators
Johnson & Johnson
- Regional Quality & Compliance Engineer: External Manufaturing
New Brunswick2013 - 2014Manage the assigned external manufactuers portfolio against an acceptable GMP status
Implementation of the worldwide initiatives and other quality improvements at the external manufacturing sites
Manage quality issues (i.e. quality holds, phase I failures, rejects, etc.) and lead on-site investigations
Assure a continuous improvement process of the External Manufacturers through KPI and Management Action Plan and CAPA follow up
Take part in the implementation of the different QA projects / new Worldwide Standard Procedures at a regional and global level
Support to post launch lifecycle management: NC/CAPA, complaints managements, change control at external manufacturing sites
Support team in coordination of initiatives
QA support in BCP / Reformulation / CIPs
GlaxoSmithKline
- Quality Control Microbiologist/ QIP Aseptic Practices
Marly-le-Roi 2012 - 2012Support production/QA/validation in the assessment of processes for bioburden & endotoxin risks (including raw materials) based on an internal guideline, existing bibliography and QC data.
Approval of risk assessment’s protocols and reports
Propose and document additional tests & rational following the assessment
Evaluate the necessity to continue tests which aren’t in product release plan based on processes risk assessment
For maintained tests, initiate & coordinate change controls, validations and master data revision.
Support for QIP Practices
