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Quality Systems Manager

Experis Belgium | Brussels | Permanent, Full-time

Published on Jobat.be 47 days ago

QUALITY SYSTEMS MANAGER

Our client is a pharmaceutical industry located in Brussels areas.

Quality Systems Manager

Job 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

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

  • Actively contribute to continuous improvement plan of the company :
    • Developing and implementing a Quality System based on Business process approach
    • Managing Operational Excellence initiatives
  • Manage the requalification plan to maintain the accurate validation / qualification state of facilities and systems
  • Collaborate and participate 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 :
  • Evaluation / Approval of deviation and support to related investigations
  • Operate the change control system (risk assessment, assessment of validation / qualification needs ; follow up )
  • Operate the CAPA system
  • Work with relevant departments to ensure timely closure of quality actions / findings
  • Perform inspections/internal audits and provide quality oversight for the inspection/ audit program
  • Collaborate with operations to resolve compliance matters

Keywords: quality, "quality systems", "quality systems manager", "quality assurance", improve, compliance, "problem solver", systems, validation, traceability, compliance, audits

Profile

  • Engineering degree
  • 8 years experience with 3 years in an operational role in a GMP environment
  • Very good knowledge of GxP in a regulated environment
  • Knowledge of risk assessment / validation /quality systems
  • Excellent accuracy and attention to detail
  • Excellent interpersonal skills
  • Strong problems solving skills, issue resolution and root cause analysis
  • Highly Flexible and Adaptable. Able to work independently in a fast paced multitasking environment
  • Knowledge of Quality Software Systems( Trackwise , Lab software ,…) is an asset
  • Good knowledges in English and French

Offer

Our client offer an exciting role in a dynamic team as well as a chance to further develop your skills. A permanent contract with an attractive salary package and extra-legal benefits.

Contact me at 02 389 11 76 or diane.louppe @ experis.be

More info

Experis Belgium
Diane LOUPPE

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    Characteristics

    Requirements

    • Master (University or Higher Education Long Type)
    • English, French

    Offer

    • Permanent
    • Full-time

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