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Operations Support Lead

SCIENCE TALENTS in BRUSSEL
time Online sinds 30 oktober 2024 - Vaste jobs

  • Coordinate, manage and control all quality aspects related to support production activities:
    • Documentation (incl.Procedures, logbooks, enz.)
    • Back-up for the Operations supervisor
    • Inspection on documentation and GMP housekeeping in the support production zones
  • Control QMS documentation (in line with c.GMP) in collaboration with MS&T and Quality:
    • Deviations/events, and CAPA
    • Support communication concerning KPI’s related to quality aspects in Production
  • 2nd point of contact representing Supporting Production quality matters in internal & external audits
  • Support optimisations of current processes within the support production areas
  • Provides support to writing and revising SOPs and associated documents
  • Works daily in a cleanroom manufacturing environment.
  • Controls and maintains the environment (equipment & facility cleaning and environmental monitoring) of the GMP production areas
  • Manage packing, sealing and sterilisation of materials and documents
  • Manage timely transfer of apheresis material, raw materials, consumables to the applicable clean room and manage timely final product transfer
  • Manage inventory counts, preparation of internal order
  • Be present at the daily start of shift operations meetings and the daily wrap up production meetings
  • Act as a SPOC to the logistics warehouse for the material availability in the supporting production areas.
  • Manage inventory in the WIP and storage of cleaning agents.
  • Communicates clearly with the Supervisor and Operations Technical Clean Room Lead to highlight on clean room status/material transfer status or any items related to safety, quality and efficiency

Senior Quality Assurance

MAANDAG BELGIUM in BRUSSEL
time Online sinds 6 november 2024 - Vaste jobs
In deze rol speel je een sleutelrol in de implementatie en het onderhoud van lokale Quality Management Systems (QMS), en bied je support bij het verzekeren van productkwaliteit en naleving van regelgeving.Je belangrijkste verantwoordelijkheden bestaan uit:Lokale QMS beheer: Het opstellen, implementeren en onderhouden van procedures om de lokale kwaliteitseisen te waarborgen.Training en beoordeling: Zorgen dat het personeel goed opgeleid is én dat de training effectief is door middel van evaluaties.Kwaliteitsbeheer Product Quality Complaints (PQC’s): Van de klacht tot het productieproces, jij zorgt voor een vloeiende afhandeling, inclusief het identificeren van trends.Beheer van Counterfeit en Diversion zaken: Herkenning en afhandeling van verdachte producten of gevallen van manipulatie.Doktersstalen: Verantwoordelijkheid voor distributie, opslag en tracering.Herroepingen en recalls: Lokale coördinatie en uitvoering.Afhandeling van afwijkingen (CAPA): Identificeren, opvolgen en waar nodig bijsturen.Logistieke controle: Van temperatuurbeheersing tot conformiteitscontrole van medische hulpmiddelen, jij waakt over het volledige proces.Management van subcontractors en Third Party Logistics: Kwaliteitsbewaking van alle externe partners, zodat distributie en opslag aan de strenge kwaliteitsnormen voldoen.Voor wie is deze functie?Ben jij een nauwkeurige en gedreven professional met een achtergrond in GDP, en wil jij bijdragen aan kwaliteitsbeheer in de farmaceutische wereld?

Production Assistant Supervisor

SCIENCE TALENTS in BRUSSEL
time Online sinds 13 november 2024 - Vaste jobs

As Plant Senior Supervisor you will provide strategic operational oversight for all production and operating process for a single plant or multiple plants with moderate complexity.In this role, you will oversee safety, quality, operational effectiveness and financial performance.

  • Ensures employee, food and feed safety and environmental compliance program standards and goals are implemented.
  • Accountable for all internal and external operating and regulatory procedures on employee, food and feed safety
  • including strategic and tactical execution in alignment with corporate environment, health and safety and food safety,
  • quality and regulatory functions as well as government regulations.
  • Establish and deploy operational priorities for a single plant or multiple plants with moderate complexity.
  • Leads strategic and tactical operations and quality management deliverables to ensure customer, product and quality
  • standard requirements are met within specifications.
  • Leads, directs and controls capital and operating budgets for a single plant or multiple plants with moderate complexity to achieve medium term outlook financial performance objectives set by the business.
  • Ensure and hold direct reports accountable for meeting and controlling operating expenses and established targets.
  • Oversee the overall operational management and implement operational efficiency improvements which may include
  • standardization of plant information manufacturing systems, quality control, safety, production reliability excellence
  • and maintenance and operators best practices.
  • Lead and develop a team, coach and make decisions related to talent management, hiring, performance, and
  • disciplinary actions.