QS Manager
SIRE
Belgium
5 dagen geleden

The company

Our client is a professional organisation, based in Belgium. .

Role description

s part of his / her role the Quality Systems Manager will ensure :

  • the continuous improvement plan is implemented
  • the facilities / equipment’s / systems are properly validated / qualified acc. GMP guidelines
  • Responsibilities

    Ensure the review / approval of documentation pertinent to equipment / systems validation / qualification is timely performed to achieve compliance to procedures and regulatory requirements.

    Provide quality guidance for the development of the validation approach

    Actively contribute to continuous improvement plan :

    Developing and implementing a Quality System based on Business process approach

    Managing Operational Excellence initiatives

    Collaboration and participation in projects as Quality Representative for equipment / systems validation / qualification.

    Assure requirements traceability throughout the whole project validation file

    Manage the requalification plan to maintain the accurate validation / qualification state of facilities and systems.

    Requirements

    o8 years experiences with 3 years in an operational role in a GMP environment

    oVery good knowledge of GxP in a regulated environment

    oKnowledge of risk assessment / validation / quality systems

    oExcellent accuracy and attention to detail

    oExcellent interpersonal skills

    oStrong problems solving skills, issue resolution and root cause analysis

    oHighly Flexible and Adaptable. Able to work independently in a fast paced multitasking environment

    oWorking knowledge of computer packages

    oKnowledge of Quality Software Systems( Trackwise , Lab software , ) is an asset

    oLanguage : English , French

    Other information

    Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Greg Silberstein.

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