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Imen CHOUCHENE

Paris

En résumé

Main skills:
-Have an appropriate education in science and experience in quality topics
-Able to take a logical and analytical approach to solving problems and resolving issue related to quality product during manufacturing or related to marketed product.
-Perseverant and self-motivated: able to find a way through, even when the going gets tough
-Self-confident and sociable
-Makes sound and effective quality decision under pressure
-Diplomatic in communication
-Show effective communication skills
-Comfortable with working independently
-Able to lead and work effectively in-cross functional team & collaborate
-Computer literate


Mes compétences :
Bonnes Pratiques de Fabrication
Norme ISO 9001
AMDEC/FMECA
Analyse de risque
KPI
Assurance qualité
Audit qualité
Audit interne
Qualité
standards implementation
managed third party contractors
deviation handling
develop bio
Warehouses
Sage Accounting Software
Risk assessment
Risk Analysis
Quality System Implementation & Management
Preparation of Sectorial plan / Reporting
OOT handling
Microsoft PowerPoint
Microsoft Excel
Microsoft Access
Internal Audit
ISO 900X Standard
Distribution Centres
Cold Storage
CAPA

Entreprises

  • Pfizer - AFFILIATE QUALITY OFFICER

    Paris 2015 - maintenant Affiliate quality officer north and west africa.
    The key role of the affiliate quality operations officer is to establish and maintain an appropriate and sustainable Product Quality System and Quality Culture at the Pfizer country office in order to insure compliance with Pfizer and regulatory authority expectations.
    In addition the AQO will be the main point of contact for the investigation and resolution of all product quality issues discovred or originating in the Pfizer Country Office and for interacting with the relevent local stakeholders and PGS on such issues.
    Also the AQO will monitor the product quality and compliance activities at the PCO to ensure current regulatory expectations are met,and facilitate internal and regulatory GMP inspection.

    Main Accountabilities:

    -Resolution of product quality compliance issues

    *Deviation management
    *Product complaint handling
    *Notification to management

    -Implementation of product quality system
    -Assessment of product quality system
    -Local product disposition (release of imported product)
    -Inspections and Internal audit
    -Local contractor quality oversight
    -Oversight of local repackaging and Relabeling operations
    -Development and maintenance of consistent quality cultu

  • Pfizer pharmaceuticals Tunisia- Pfizer Global Supply - Affiliate Quality Officer

    2015 - maintenant Affiliate Quality Officer Tunisia-Libya-Algeria-Morocco-West Africa
    Resolution of product quality compliance issues
    Quality System Implementation & Management
    Local product disposition (release of imported product)
    Supporting Inspections (external & internal)
    Quality oversight of PCO managed third party contractors, manufacturers, local packaging/labeling partners, analytical
    laboratories and distribution centers
    Oversight of local repackaging and Relabeling operations
    Ensuring Quality Agreements are in-place where necessary and their requirements are met.
    Review and sign-off and management of amendments.
    Supporting the validation of warehouse and cold store, shipping system qualification; product returns process; Good Distribution
    Practice (GDP) standards implementation
    Communications to Board of Health /Recall Activities: Preparing/submitting responses
    Development and maintenance of consistent quality culture

  • Pharmaceutical Laboratory - Medical sales representative

    2014 - 2014 Identifying and establishing new business
    Demonstrating or presenting products to healthcare staff including doctors, nurses and pharmacists
    Preparation of Sectorial plan / Reporting to the management

  • Laboratoires Teriak - Quality assurance engineer

    Tunis 2012 - 2014 Main tasks:
    -Deviation handling and management
    -OOS and OOT handling
    -Elaborate risk assesments
    -Participate in investigation and resolution of all product quality issues discovered in the site
    -Animate quality commitees
    -Elaborate internal quality key performance indicator
    -Quality complaint handling
    -Daily GMP's assesment
    -Establishment and updating of deviation handling and risk analysis SOPs
    -Bach record evaluation before release
    -Establishment of annual revew product
    -Internal auditor

  • Pharmaceutical industry - TERIAK - Assurance quality engineer

    2012 - 2014 Deviation handling and management
    OOS and OOT handling
    Participate in investigation and resolution of all product quality issues discovered
    Animate quality committees
    Elaborate internal quality key performance indicator
    Quality complaint handling
    Establishment and updating of deviation handling and risk analysis SOPs
    Internal auditor
    Elaborate risk assessments / Daily GMP's assessment

  • laboratoire biodymia - Graduate Process Engineer

    2011 - 2011 Thesis title: `lactic bacteria incorporation into caseinate alginate polymers to develop bio protective packaging'

  • INSAT - Etudiante

    Tunis 2007 - 2012

Formations

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