Quality Systems Manager
SIRE
Waals-Brabant, Belgium
3 dagen geleden

The company

Our client is a professional organisation, based in Waals-Brabant Belgium. .

Role description

The Quality Systems Manager will be part of the Quality Assurance Department and will report into the Head of Quality. Under the direction of the reporting manager, he / she will continuously improve Compliance systems, strengthen quality awareness and investigate quality issues using applicable process improvement and problem solving techniques to assure successful outcomes of Company and external Health Authority inspections

Responsibilities

oDeveloping and implementing a Quality System based on Business process approach

oManaging Operational Excellence initiatives

  • Manage the requalification plan to maintain the accurate validation / qualification state of facilities and systems.
  • Collaboration and participation in projects as Quality Representative for equipment / systems validation / qualification.
  • Provide quality guidance for the development of the validation approach.
  • Assure requirements traceability throughout the whole project validation file
  • Ensure the review / approval of documentation pertinent to equipment / systems validation / qualification is timely performed to achieve compliance to procedures and regulatory requirements.
  • As member of the Quality department :

    oEvaluation / Approval of deviation and support to related investigations

    oOperate the change control system (risk assessment, assessment of validation / qualification needs ; follow up )

    oOperate the CAPA system

    oWork with relevant departments to ensure timely closure of quality actions / findings

    oPerform inspections / internal audits and provide quality oversight for the inspection / audit program

    oCollaborate with operations to resolve compliance matters

    oEngineering degree

    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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