Job Properties
  • Job Type
    Full-time Position
  • Category
    Security & Surveillance
  • Languages
    English
  • Experience Required
    Entry
  • Degree Required
    Bachelor
    • Province
      Groningen
    • Date Posted
      September 28,2021
    • JSS
    • VISA
    • MOCKINTERVIEW
    • IMG_6430
    • Career Consultation
    • COVERLETTER CHECK
    • CV CHECK

    Laboratory Team Lead

    You will be responsible for the management of the AMO Groningen testing laboratories, and the QA technician staff to ensure optimal QC support to the organization (operations and projects). Drive compliance improvements and ensure applicable site, division, corporate and external compliance requirements are met. Provides policy input to site quality head function.


    GMP/CORE JOB RESPONSIBILTIES


    Management and coordination of team activities, including but not limited to;

    • Complaint handling
    • Execution of; chemical, optical, mechanical and microbiological product related testing.
    • Site Environmental monitoring program
    • Final product release by Device History Record review.
    • Sterility assurance and associated validations.
    • Execution and review of statistical analysis supporting the implementation of statistical process control, sampling and other quality tools.
    • The generation and review of qualification and validation protocols and reports
    • Assigning staff based on priority and individual competencies / experience.
    • Co-ordination with staff members and other departments to ensure that targets / goals are achieved.
    • As appropriate escalation of issues to site Quality head function
    • Ensure that quality awareness is improved in the organization.

    Execution of site / division and corporate policies to ensure compliance to applicable internal and external regulatory requirements:

    • Generation of department plan to support site QA planning and site business plan.
    • Generation and control of department budget on the basis of expected developments (projects, capacity and consumables).
    • Ensure appropriate employee behaviors and where necessary address employee behavior issues with respect to AMO procedures (including but not limited to; safety, hygiene, compliance etc)


    Management of staff:

    • Training and development of staff.
    • Conducting departmental meetings
    • Conduction performance reviews.
    • Recruitment and selection of new staff (as required)

    Qualifications


    REQUIREMENTS

    • Education at higher vocational or university level (preferably in the subject of chemistry, microbiology or another technical subject)
    • Education at higher vocational or university level (preferably in the subject of chemistry, microbiology or another technical subject)
    • Knowledge of relevant GMP, QSR CFR 820 , ISO 13485, ISO 14971
    • Knowledge of relevant work instructions and procedures
    • Knowledge of MS Office

    Attitude/Competencies:

    • Flexible in undertaking tasks and working hours
    • Ability to operate and maintain relationships at different levels
    • Communication skills
    • Decisive and with the ability to set the correct priorities
    • Has a helicopter view
    • Target-led
    • Client-led
    • Ability to realise close-knit and high-quality alliances
    • Has strong leadership qualities
    • Excellent command of the English language (verbal and
    • written)

    Primary Location
    Netherlands-Groningen-Groningen-
    Organization
    AMO Groningen BV (8358)
    Job Function
    Quality
    Requisition ID
    2105966222W
     
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