Dieses Jobangebot ist archiviert und steht nicht mehr zur Verfügung.
Vakante Jobangebote finden Sie unter Projekte.

QC Microbiology Technician

Eingestellt von Quanta Consultancy Services

Gesuchte Skills: Support

Projektbeschreibung

Role: QC Microbiology Technician
Type - Initial 6 months contract
Location - Ireland, South East

One of our key clients, a global Pharmaceutical leader, is looking for a QC Microbiology Technician to be responsible for carrying out the quality administration of the environmental, utility monitoring programs, ensuring compliance with internal and worldwide regulatory standards.

Key Responsibilities:
Carrying out routine testing and test method validation/qualification of drug product for microbiological/chemical attributes as required.
Perform environmental monitoring, water monitoring, lab support testing in accordance with GLP, GMP and regulatory requirements.
Document generation and review as identified by the Microbiology Laboratory Coach.
Perform testing of drug substance and drug product in accordance with the validated methods, ensuring compliance to regulatory filings. Performing method qualifications/validations of new products in line with site Plan of Record.
Support process simulations by performing inspection, reconciliation and growth promotion testing as required.
Support/perform environmental monitoring of clean rooms and controlled environments. Preparation of trend reports for review by QA Lead Technician/Micro Lab Coach as applicable and other associated groups.
Operation of laboratory equipment and stock levels and perform general housekeeping activities.
Participate in effective writing/revising/rolling out of accurate operational procedures, training materials and procedures for various Quality systems; ensure all work is subsequently carried out in line with same.
Actively participate and promote continuous improvement in the Microbiology Laboratory, by leading and active participation in system failure investigations and investigation reports, execution/development of change control and contribution to Kaizen events as appropriate.
Manage root cause analysis of system failures, substandard equipment performance, using standard tools and methods, to resolve system issues eg FMEA, Fishbone diagrams, 5 why's etc.; oversee and implement subsequent corrective action through the change management system.
To comply with Global Policies, Procedures and Guidelines, regulatory requirements and execution of current Good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.

Key Requirements:
Bachelors Degree or higher preferred; ideally in a Science discipline
Experience ideally in a pharmaceutical manufacturing, preferably GMP setting.

Projektdetails

  • Einsatzort:

    Carlow, Irland

  • Projektbeginn:

    asap

  • Projektdauer:

    Initially 6 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

  • Skills:

    support

Quanta Consultancy Services