Google Play

Profil CV N°650650

Profil

Contactez ce profil pour un recrutement
Nom : *********
Prénom : ****
Téléphone : +1**********
Email : ******@******
Né(e) le : ********
Nationalité : ********
Adresse : **************************************************

CV attaché :

Détails du profil

Types de métiers recherchés
» Production, maintenance, qualité
Expérience professionnelle
Expérience entre 2 ans et 5 ans
» Chimie, pétrochimie, matières premières
» Industrie pharmaceutique
» Luxe, cosmétiques
Expérience professionnelle: 
Depuis 12.2020
Quality Assurance Manager
Tetra BioPharma
- Prioritize tasks between the QA and different departments, external labs and external contractors - Be responsible for all aspects of documentation flow, to review standards, policies, and procedures - Support in developing a drug, support in creating, inspecting and evaluating manufacturing process - Work in collaboration with Regulatory and Clinical departments - Evaluate vendors; perform virtual and on site audits; write audit reports; establish quality agreement, perform oversight of vendors - Manage the training program, perform training of employees, create training plans, assess training of employees and maintain training matrix - Oversee the stability program, review and approve stability protocols and reports - Review, approve, monitor change request, and maintain change control system - Oversee Release/Reject of Drug Substance and Drug Product - Manage, review and approve Non-conformances investigation, perform root cause analysis; work on deviation, OOS, OOT, complaint - Ensure Quality Team is performing work in compliance with GMPs, GCPs, GLPs, SOPs - Assign work to Quality Team with minimal oversight while ensuring target timelines are met - Perform Risk Assessment & Risk Management - Participate/Lead inspections from different regulatory bodies, and write/implement CAPA following inspection report - Keep supervisor inform regarding risks related to products, process and system, and participate toManagement Review Meetings
01.2019 - 12.2020
Senior Quality Assurance Specialist
Tetra BioPharma
- Writing and revising SOPs according to GMP, GCP and regulatory requirements - Drug development program: support in developing a drug, support in creating manufacturing process - Vendor qualification program: evaluating vendors and background check; performing audits; writingaudit reports; establishing quality agreement - Maintain training program - Specification: support in establishing specifications, review of current specification - Stability program: support in stability program, establishing stability protocols and execution - Change Control Management - Non-conformances investigation: writing investigation reports on product quality failure or non-conformance; performing root cause analysis; working in close collaboration with Quality Control maintaining deviation, OOS, OOT, complaint logs - Risk Assessment & Risk Management: impact analysis, risk analysis, risk control, gap analysis, risk review - CAPA: initiating, tracking, implementing, executing, trending, effectiveness and closure - Participating in inspections and audits, follow-up and CAPA writing and implementation - Creating and reviewing budgets associated with company’s projects
05.2018 - 01.2019
Quality Assurance Specialist
Delon Laboratories
- Writing and revising SOPs according to cGMP and regulatory requirements - Change Control Management: evaluating change request for equipment, processes, systems,formulation; maintaining change control log; closing change upon implementation - Release of products: reviewing/approving manufacturing and packaging batch records for finishedproduct, reviewing Certificate of Analysis, producing batch records - Non conformances investigation: Deviation, OOS, Market Complaint; writing investigation reports;maintaining logs; performing risk assessment/analysis; establishing CAPA
09.2014 - 09.2015
Technician/Coordinator in pharmaceutical production
KABS Laboratories
- Following SOP and GMPs regulation to operate production - Quality assurance : writing deviation, batch record review, participating in process validation - Production in sterile area class A and B: Formulation, Sterilization, Lyophilisation, Filling and Cappingof vials - Production of tablets and capsules, production class C and D: Granulation, Blend, Compression,Coating - Reconcile batch records and fill out the entire necessary documents - Support in cleaning validation - Support in validation of equipment (IQ/OQ/PQ)
Laura Eyoum Jong
Compétences
Expertise in Pharmaceutical/Natural Health Products/cosmetic/cannabis industries. Proficient in GMP, GCP, GLP, GDP, FDA (21 CFR part 210&211), Health Canada (Food and Drug Act Division C,Division 2), EudraLex Volume 4. Health Canada (GUI-0001, GUI-0023, GUI-0036), FDA (21 CFR parts 210 and 211), ICH Q9, ICH Q10, ICHE6(R2), EudraLexVolume 4. A dynamic, organized, and team-spirited person. Team-oriented, doer and attentive person. Organizational andanalytical skills. Calm and adaptable to all situation. Certified Quality Auditor. Bilingual English and French. Project Management • Good Manufacturing Practice (GMP) • Standard Operating Procedure (SOP) • Research • Real-Time Polymerase Chain Reaction (qPCR) • Good Clinical Practice (GCP) • RiskManagement • Pharmaceutics • Good Distribution Practice (GDP) • Natural Health Products
Formation
Bac+5 et plus
09.2010 - 05.2014
Bachelor in Biochemistry
Université de Montréal
- Relevant coursework: immunology and microbiology, technical of laboratory for biochemist, organicchemistry, metabolism, genetic, ethics. - Utilisation of several techniques: qPCR, immunochemistry, western-blot, ELISA, DNA extraction,immunoelectrophoresis, immunoassay, southern-blot, protein imaging, HPLC, GC/MS
05.2016 - 05.2018
Master of Neurobiology
Université Laval
Project : "New delta ribozymes targeting tau mRNA as therapeutics for tauopathies" - Courses: Neurosciences, ethic in science - Writing a master project, writing a master thesis - Laboratory work: cell culture, molecular cloning, transfection, transduction, ARN, ADN extraction, RT-qPCR, viral production, western-blot - Project Management: protocols improvement, review of scientific article, establish new methods - Participating in conferences, presenting projects
Langues
anglaiscourant
françaismaternelle
Plus d'informations
dans 1 mois
Dakar - Diourbel - Fatick - Kaffrine - Kaolack - Kédougou - Kolda - Louga - Matam - Saint-Louis - Sédhiou - Tambacounda - Thiès - Ziguinchor - International
Lieu de résidence : Montreal
CDI - CDD - Intérim - Stage - Freelance - Alternance - Temps partiel
10.06.2021
14

Autres profils susceptibles de vous intéresser

Profil n°00653480
  • Expérience professionnelle : Expérience > 10 ans
  • Secteur d´activité: Automobile, matériels de transport, réparation - Aéronautique, navale - Electricité, eau, gaz, nucléaire, énergie - Manutention - Services aéroportuaires et maritimes
  • Formation:
    Depuis 02.2021
    Responsable de site Chef d’atelier
    john deere / JCB
  • Langues: Allemand (courant), Anglais (courant), Arabe (débutant) & Français (courant)
  • Compétences :

    • Moteurs Diesel ; expériences de marques et puissances variées, démontages, remontages
    ...

  • Profil n°00655852
  • Expérience professionnelle : Expérience entre 2 ans et 5 ans
  • Secteur d´activité: BTP, constructionImmobilier, architecture, urbanismeIngénierie, études développementQualité, méthodes
  • Formation:
    09.2011 - 06.2014
    Technicien Supérieur en génie civil
    Institut Supérieur des Etudes Technologiques de Nabeul, TUNISIE
    09.2014 - 06.2017
    Ingénieur Génie Civil
    Ecole Polytechnique Sousse , TUNISIE
  • Langues: Allemand (débutant), Anglais (bon niveau), Arabe (maternelle) & Français (courant)
  • Compétences :

    "Dynamique", "Motivé", "Créatif", "Responsable", "Communicatif" et "Compétant"

  • Profil n°00653546
  • Expérience professionnelle : Débutant < 2 ans
  • Secteur d´activité: Informatique, SSII, InternetMaintenance, entretien, service après venteÉdition, imprimerie
  • Formation:
    10.2019 - 07.2021
    SYSTEME ET RESEAU INFORMATIQUE
    Institut SudInfo
  • Langues: Français (bon niveau)
  • Compétences :

    Expérience dans le domaine

  • Profil n°00654160
  • Expérience professionnelle : Etudiant, jeune diplômé
  • Secteur d´activité: AgroalimentaireChimie, pétrochimie, matières premièresImport, exportIndustrie, production, fabrication, autresProduits de grande consommation
  • Formation:
    09.2018 - 05.2021
    management des organistions agricoles et agroalimentaires
    Institut Supérieur de Management (ISM)
  • Langues: Anglais (débutant) & Français (bon niveau)
  • Compétences :

    Dynamisme
    Rigueur
    Efficacité
    Endurance