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CoCEPTIO is hiring a Qualification/Validation Expert

OUR CULTURE AND WORK ENVIRONMENT

CoCEPTIO, a business & technical expert active in very specific sectors (pharma, biotech, comestics, food-processing sector …), strives to be the best European stakeholder in the conception and execution of high-valued industrial projects.  CoCEPTIO is also establishing an agile management where trust, autonomy and responsibilities are the key words for our collaborators, who feel fulfilled and spontaneously contribute to the company growth.

 

1. MAJOR ROLE

As expert of the Qualification/Validation discipline, you define validation plans of processes, installations and systems as well as qualification plans of the equipments and devices and control their implementation.

The Qualification/Validation expert also supports the responsible of the discipline in the “skills” department in the project definition and the development of the Quality policy of the concerned department.

 

2. OPERATIONAL RESPONSIBILITIES

2.1.         On Project Level

Ensure, in coordination with the project team, in the different disciplines, the following responsibilities:

  • Define and implement process validation plans
  • Coordinate and plan validation and qualification activities
  • Control the implementation of process validation
  • Control protocols before execution
  • Control validation/qualification reports
  • Check the qualification of the equipments and processes
  • Create and host process validation groups
  • Contribute to the project definition according to the client’s requests and needs
  • Deliver specific deliverables (SOP coating, cleaning, MDF strategy, EM strategy, …)
  • Take care of the Gap Analysis GMP/PIC’s

 

2.2.         As support of Leader Equipments Discipline

  • Define the URS of the process equipments (isolators, etc.)
  • Conduct risk analysis for process equipments (isolators, etc.)

 

2.3.         In the Office

  • Ensure the training and coaching of internal and external staff on Qualification/Validation matters
  • Promote the regulatory approach on validation matter
  • Support the responsible of Department discipline in the control of the projects’ quality procedure implementation

3. MANAGEMENT RESPONSIBILITIES

  • Follow-up the work delivery to ensure the approriate invoicing
  • Inform the Project Manager of each additional request and/or each scope change not foreseen in the project
  • Prevent and/or identify the drifts in the execution of the missions (re. timing, costs, quality, …) in view of taking corrective actions
  • Participate in the identification of new clients’ needs

 

4. PROFILE AND MAJOR SKILLS

  • Master degree Civil Engineer or Industrial Engineer ou Industrial Pharmacist;
  • At least 5 years experience in the industrial sector, with a good knowledge of production, validation and process development;
  • Perfect knowledge of the quality environment and especially in the industrial sector;
  • You are clients-oriented (internal and external) and you rapidly translate their needs in a simple and clear language
  • You regularly update your skills in Qualification/Validation matters
  • English confirmed
  • Good knowledge of MS Office

 

 

Interested in a new professional start at CoCEPTIO?  Please contact Thierry Marchandisse, HR officer, at info@coceptio.be

 

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