LOC Quality Manager (50%)

For a client in the region of Zaventem, we are now looking for a Quality Manager (50%). 

Are you...

  • available for the next six months?
  • willing to work 50%?
  • experienced in the processes of a pharma production environment?
  • fluent in Dutch/English/French?

Then this project might be the next highlight on your resume!

Responsibilities 
Management roles & responsibilities
  • Ensure that (new) regulations are implemented in the company
  • All compliance issues including local quality systems in GMP and GDP and Regulatory matters (authorizations, supply…).
  • To ensure the quality aspects through participation in cross-organisational projects, reporting systems and meetings (product maintenance, change controls, deviations, complaints, recall, …)
  • QA function with respect to external suppliers and partners directly connected to the manufacturing site (e.g. qualification, audits, quality agreements, evaluation)
  • To promote a good knowledge level in the QA area by setting up a training program for the Quality Unit personnel
Functional roles & responsibilities
  • To prepare and review the documents linked to the implementation of the Quality Policy and the Quality Management System (SOPs, WI’s…).
  • To implement correct written procedures, in conformity with internal and international guidelines.
  • To guarantee that a good documentation system is in place.
  • Participates in the solving of different problems and support for corrective actions in the GxP areas.
  • Organisation and performance of Quality Management Review.
  • Organisation and performance of self-inspections in GxP relevant areas.
  • Reporting to the Global Operation Quality: Monthly reporting, inputs to annual report KPIs and Product recall reports.
  • QA function with respect to external suppliers such as qualification, audits, and quality agreements. 
  • Provide help for the establishment of Quality Agreement with the partners.
  • Act as an expert in quality processes tracked in EQMS.
  • Participate in the periodic review of the Quality Manual.
  • Maintain his/her knowledge level by suitable training: 
  • Participate in initial and continued training and qualification activities as required for the job function 
  • Complete training within the specified timeframe
  • Complete all required training prior to performing assigned regulated job activities and work under supervision until qualified to work independently
  • Document completed training per local requirements
  • Seek clarification as needed to ensure understanding of job requirements and applicability of training completed
  • Demonstrate knowledge or skills gained from completion of required training and qualification
  • Participate in retraining when there is a knowledge or skill gap and when required refresher training is offered 
Profile 
Education and on the job experience
Min. 3 years of experience as Quality Assurance Officer or Manager
 
Language skills
 
Spoken: Dutch, French, English (fluently)
Written: Dutch, French, English (fluently)
 
PC skills Easiness to work with digital platforms
 
Specific and current knowledge of international rules and guidelines for the pharmaceutical industry, Quality Management Systems, GMP & GDP and Regulatory Affairs.
 
Functional and process related knowledge, skills and abilities
  • Experience in a pharmaceutical environment is required
  • Autonomous and assume responsibilities
  • Analytical mind
  • Decision making based on scientific aspect and risk evaluation
Contact Information 

Amandine Planche
010.68.53.30
amandine.planche@valesta.com

Anneleen De Vos
015 21 11 04
anneleen.devos@valesta.com

Application form : LOC Quality Manager (50%)

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