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Summary

experienced Manufacturing lead with a demonstrated history of working in the Pharmaceuticals industry. strong Manufacturing professional skilled in Pharmaceutics, Internal Audit, Pharmaceutical Research.

Experiences

Current Experience

  • Manufacturing Lead


    Since October 2015
    • supervision of technicians during Manufacturing Operations. • plan and manage assigned resources to deliver Manufacturing projects and technologies to agreed timelines in accordance with company Policy/ cGMP and support equipment Procurement and Validation activities. • proactively manage and maintain Manufacturing operation to cGMP, quality and ehs standards including inspections/audits and effective action to rectify non Compliance. • manage issues effectively providing compliant/ technical solutions and identify/ deliver improvements • support and evaluate new technologies, managing their implementation when required. • generate and approve all GMP Documentation associated with the ldm facility and batch manufacture • control of activities undertaken within the facility • to take a production lead in liaising with partners to deliver development activities into Clinical manufacture • to support Operations teams in the deviation managementb by writting deviations with the right level of quality, performing Root Cause Analysis using appropriate tools (6m, 5 why’s, problem statement). define suitable capa with internal customers (production, technical services, qa) • Supervision of technicians during manufacturing operations. • Plan and manage assigned resources to deliver manufacturing projects and technologies to agreed timelines in accordance with company policy/ cGMP and support equipment procurement and validation activities. • Proactively manage and maintain manufacturing operation to cGMP, quality and EHS standards including inspections/audits and effective action to rectify non compliance. • Manage issues effectively providing compliant/ technical solutions and identify/ deliver improvements • Support and evaluate new technologies, managing their implementation when required. • Generate and approve all GMP documentation associated with the LDM facility and batch manufacture • Control of activities undertaken within the facility • To take a production lead in liaising with partners to deliver development activities into clinical manufacture • To support operations teams in the deviation managementb by writting deviations with the right level of quality, performing root cause analysis using appropriate tools (6M, 5 Why’s, problem statement). Define suitable CAPA with internal customers (Production, Technical Services, QA)

Past Experience

  • Production Supervisor

    November 2011 --- September 2015
    Manufacturing experience in Formulation, preparation services, sterile filling and/or inspection and Packaging. responsible for the overall Planning, coordination, supervision, and work scheduling of a sterile Manufacturing and Packaging department. responsible for Training department personnel. knowledge of Sterilization theory, knowledge of equipment, familiarity with Aseptic Manufacturing processes, knowledge of cgmps

  • Industrial Pharmacist

    September 2008 --- November 2011
    manufacture of sterile preparations, i.v. solutions in small and large volume. Research for new products and new sterile Pharmaceutical Technology

  • Pharmacist

    March 2006 --- August 2008
    accurately dispensing drugs to patients according to a doctors prescription. checking prescriptions for errors & making sure they are appropriate for patients.  measuring, Packaging, labeling and recording medications issued to patients.  instructing patients on how to use medications, possible side effects and storage.  contacting and working closely with other Healthcare professionals.  answering questions from patients and staff about medicines.  ensuring the accuracy of all prescriptions, products and services supplied.  helping to develop the Pharmacy's electronic discharge system.  managing and resolving complaints.  talking to regular patients to see how their Treatment is going.  able to trains and supervise Pharmacy assistants.  communicating with customers sympathetically and supportively.  giving private consultations when required.  maintaining Pharmaceutical stock, creating inventories and ordering more drugs.

Personality

Self Assessment :
CollaborationAttention to detailCommunicativeCritical thinkingFlexibilityInnovative thinkingInterest in knowledgeResponsibilitySelf-confidenceTrust

Knowledge

LinkedIn Assessment :
Pharmaceutical IndustryPharmaceuticsGMPPharmacyRegulatory affairsManufacturingRegulatory submissionsClinical researchFormulationClinical PharmacyPharmacovigilanceSOPPharmacokineticsPharmacistsFDAPharmacueticalsHPLConcologyPharmacy PracticeSterilizationDrug DeliveryPharmacy AutomationBiotechnologyCommunity PharmacyPharmaceutical ResearchMarket accessMedicinal ChemistryAseptic TechniqueValidationLyophilizationInternal AuditVisual InspectionCompoundingStandard Operating Procedure (SOP)U.S. Food and Drug Administration (FDA)Market access

Skills and Expertise

Self Assessment :
Create SOPs Develop protocolsArchive documentationAseptic processingAseptic techniquesAssign activitiesCoach staffCollaborate with project teamDocument data reporting systemsEnsure data integrityEstimate subject complianceLead teamsParticipate in medical reviewManufacture of GMP batchesNon-aseptic processingOrganise meetingsReport technical problemsResearch at universitiesSupervise techniciansWork collaboratively with the other members of the clinical research team

Education

  • in from Università degli Studi di Padova in 2005
  • Master's degree in Chemistry and Pharmaceutical Technology from Università degli Studi di Padova in 2005

Training and Certification

  • Stepping Up to become a Supervisor in 2016 Training
  • Confined Space Entry-Medium risk in 2016 Certification

Languages

BrightOwl Assessment:
Self Assessment:
ALBANIAN
Native
Italian
Full Proficiency
English
Full Proficiency

Work Preferences

  • Notice Period:
    12 weeks
  • Positions I am interested in:
    Industrial Pharmacist Production Supervisor Research Assistant Team Leader Technician
  • Work From Home:
    No
  • Work Regime:
    Permanent position
  • International:
    Yes

Area / Region

Canterbury, United Kingdom

Others

Driving License
  • No

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