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Novartis Consumer Health Switzerland
- Senior Quality Assurance Manager Quality Systems and Standard Europe - TPO
2013 - maintenant
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Warner Chilcott
- Directeur Assurance Qualite
2010 - 2013
Head of Quality Assurance – Warner Chilcott France (former P&G Pharmaceuticals)
Bondoufle Business Center – France
In charge of Quality Assurance department composed of Quality Standard group and Quality Compliance group (6 QA technicians + 3 Managers) – reporting to the Global External Operation and Compliance Associate Director and Country Manager in France - Member of the French Lead Team
-Supervise the implementation of WCRx applicable Regulations, including French regulations (Code de la Santé Publique), Eu GMP, GDP (BPD) rules, as well as WCRx global policies and procedures (for the site and with contractors)
-Represent QA in major site projects and initiatives to assure Quality standards and requirements are met
-In partnership with other WCRx QA organizations, and contractors, manage crisis as may be required, including issues relative to product quality, stability, and major complaints or recalls of marketed product
-Approve staffing plans for Quality Assurance and participate in personnel recruitment
-Supervise and is responsible for all pharmaceutical operations performed by the site : repackaging, distribution, import, recall, release and drugs transportation
-Responsible to notify to AFSSAPS all legal notifications related to the French pharmaceutical regulation: Site Master File, Headcount, major change
-Develop and provide detailed GMP/technical training programs
-Manage QA expense budget
-Support, lead and follow-up self improvement inspections, corporate audits, and inspections by Health Authorities
-As member of the French Lead Team, participate and lead in general actions relative to costs, safety, and quality, business strategy
-Represent the Company to local, national and/or regional competent authorities in matters concerning the quality of the products produced and controlled in the facility, including the hosting of such authorities during inspections, with the intent to developing strong relationships with regulatory authorities
Other specific activities: Interim Site leader role during 8 months in charge of managing all warehouse, customer service, finance, external supply operation activities on site : business continuity plan implementation, customer service reorganization in collaboration with European CS group, development of full externalization project for the distribution activities
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Procter & Gamble Pharmaceuticals
- Responsable Assurance Qualite
Asnières-sur-Seine
2007 - 2010
Quality Control Manager – Procter & Gamble Pharmaceuticals France and Warner Chilcott France
Longjumeau manufacturing site and Bondoufle site
In charge of Quality Control Laboratory at Longjumeau site (5 QC lab. technicians) + Quality Control department at Bondoufle site (3 QA technicians + 1 Manager) – reporting to the Head of Quality Assurance
Lab. activities:
-Supervision of laboratory analysis from sampling to release, according to EU Pharmacopeia, USP and internal methods, for raw materials, packaging materials and finished products
-Qualification of laboratory equipment, management of out of trend and out of specification results according to global and local SOPs
-Retain sample room transfer management : protocol implemented in collaboration with the Responsible Pharmacist, new process (with new SOP) implemented for direct sampling at CMs sites according to French legal requirements
Quality Control activities:
-Product Compliance Quality Assurance organization : batch record review and release activities of all raw materials, packaging materials and finished products (about 2000 batches per year), follow-up of stability batches with CMs and global organization, local QA SOPs update, release activities optimization by implementing reduced batch record review (release cycle time reduced by about 30 %), deviations and capas management for Bondoufle site and CMs, implementation of quality training programs based on the skill matrix, self inspection supervision
-QA site contact for several contractors located in Europe & US: contribution to the implementation of interaction model for key quality topics, day to day interaction & QA contact for all projects in collaboration with other departments (ESO, GTS, Purchasing, Regulatory Affair): such as new API implementation, new formula development, site validation …
-Quality Agreement implementation with French CMs and other WCRx sites
-Contribution to Quality Audit Corporate & French inspection preparation : no critical nor major observations since Bondoufle site opening
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Meda Manufacturing
- Responsable de Production
2002 - 2007
Production Manager (Making & Packaging department) for drinkable solution & ointment – Meda Manufacturing (Swedish Pharmaceutical Company)
Bordeaux site – France
In charge of 4 making areas (ointments, suppositories, drinkable solutions) and 10 packaging lines with 35 operators & 2 managers – reporting to the Operations Director
-Supervision of production activities in collaboration with planning & customer service departments
-Equipment calibration management (technical agreement with suppliers, SOPs implementation, planning management, deviations management in case of OOS)
-Development of new processes and new SOPs for improving technical expertise of production team (SMED, 5S, preventive maintenance, change over)
-Batch record review and deviation management in collaboration with QA and QC department
-Team member as production representative for transferring making & packaging activities from a German site to the French site: technical agreement implementation, technical documentation & SOPs optimization, training programs implementation, validation strategy development
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Procter & Gamble Pharmaceuticals
- Responsable Conditionnement formes séches
Asnières-sur-Seine
1999 - 2002
Packaging manager for solid forms (tablets, capsules) – Procter & Gamble Pharmaceuticals France
Longjumeau site – France
In charge of 7 packaging lines – 8 skus (blister cards and tubes) – 30 operators, 2 technicians – reporting to the production manager
-Supervision of packaging operation with processes and methods improvement in order to increase process reliability (5S, SMED …) – process reliability increased by about 20 % in 2 years
-Development of 3 shifts organization to deliver new business needs
-Quality systems improvement in production (line clearance, startup documentation, IPC documentation) - number of deviations decreased by about 30 %
-Development of new production organization in collaboration with QA & HR departments in order to integrate new technical skills in production (new job descriptions, skill matrix and new training programs implementation)
