Marly-le-Roi 2013 - maintenant. Context and mission:
Commissioning & Verification for new IPV facility :
- Clean utilities distribution (water, steam, O2, caustic, air, COP stations);
- Biowaste systems, drain systems.
. Roles and responsibilities:
Part of GSK integrated team for Clean utilities verification:
Follow-up of verification performed by the GSK integrated team on the different systems, Testing. Contact point with GSK C&Q (Commissioning and Qualification) and supplier: Coordination of verification activities with supplier;
UCB
- Clean utilities Engineer - Consultant (BQG)
COLOMBES2012 - 2013. Context and mission:
Supporting the set-up of a Bio Pilot Plant following verification approach ASTM-E2500-07. Start-up & Qualification for clean utilities (water, steam, gas and air) Verification planning management
. Roles and responsibilities:
Qualification leader for Clean utilities, Planning manager
Presentation for internal inspection and support to AFMPS inspection
COLOMBES2011 - 2012. Context and mission:
Supporting BQG Project Manager in the scope of a new bio-pilot plant strategic assessment (Engineering review / Risk Assessment / Quality Documentation / Planning / Workload hand-over to user).
Responsible for delivering detailed planning in order to initiate PQ phases in the shortest deadlines as well as facilitating handing-over to biopilot plant’s users,
In charge of coordinating verification activities, in order to ensure a smooth starting of all installations (facility, bioprocess equipments, utilities)
GSK Mayenne
- Junior Pharmacist-Engineer
2011 - 2011Implementation of new weighing equipment on dispensary area.
Optimization of the equipment use to decrease necessary resources to the dispensary rooms and improve ergonomics of this working station BPF standards.
- Management and training of the 14 operators team to the equipment use
- Revision of process mix
- Equipment’s load analyse
- Review of the organization of the dispensary rooms with engineering department
- Planning of transfer tests on industrial batches with logistical department
- Creation and updating of documents involved in new equipment installation
- Follow-up : Cleaning validation of new equipment and Powder transfer validation on new equipment
Adwya
- Junior Pharmacist-Engineer
La MARSA 2010 - 2010Junior Pharmacist-Engineer
Adwya Laboratoires
mai 2010 – août 2010 (4 mois)La Marsa, TUNISIA
Alpha factory productivity improvement.
- Analyse of the production process, manufacturing and packaging: value added (VSM)
- Setting up of documents in each workshop : measure running time
- Estimation of Utilisation (TRS, Takt Time)
- Wastes estimations (Pareto, 5M)
- Standardization of production process (5S)
- SMED on one tablet press machine CAM and MX82
Hôtel Dieu
- Junior Pharmacist
2009 - 2009Validation of sterility assay about Mitomycine C 0,02 % BPP standards and European pharmacopoeia.
- Production of antibiotic drops for assays under insulator
- Redaction of validation protocol and sterility assays
- Research of microbiological strains qualified suppliers
- Achievement of validation assay on Steritest® Millipore pump and of sterility assays
- Training of 2 technicians to this protocol
Doctorate in Pharmaceutical Sciences, Option Industry
Activités et associations: Poster for study case about Dexamethasone: responsible for research & development part; Responsible of UEP Industry; Participation in ALEE forum organisation, Paris V.
