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Quality Systems Sr Specialist

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Job ID R0041730 Date posted Aug. 19, 2021 Location Lessines, Belgium

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Job Description

Primary duties :

Act as Lessines’ Execution Lead for Quality Systems : mainly Deviation management

Responsibilities

  • Ensure the deployment, implementation and maintenance of the activities related to Quality Systems for the Lessines facility, mainly Deviation Management system
  • Ensure and maintain compliance with current regulations/requirements of quality systems.
    Conduct gap analyses of local Quality systems in accordance with the global Quality Systems procedures and regulations, define and implement actions
  • Monitor the Quality Systems to ensure compliance with the Global procedures and regulations and evaluate additional need for training/coarching of the users.
  • Interface with quality, manufacturing or other groups to promote adherence to the deviation process, identify improvement actions and follow up on the implementation of these actions.
  • Define, review and analyze Quality Systems’ metrics.  Define appropriate actions to maintain satisfactory metrics
  • Collaborate with the Lessines Quality Systems team members and the Takeda organization to align and improve the management of the Quality Systems.
  • Support inspections conducted by Health Authorities, Customers, and License Partners
  • Active participation to the Annual Product Quality Review process providing data’s and conclusions
  • Communicate with owners, QA disposition, supply chain and any impacted department to ensure disposition of lots impacted by a deviation.

Education and Experience Requirements

  • Bachelor’s – Master’s degree in engineering, chemistry, biology or related discipline
  • At least 3 years’ experience in Quality or related field in the pharmaceutical industry.
  • Understanding of pharmaceutical quality management systems and regulations including current GMPs & GDDPs. 

Key Skills, Abilities, and Competencies

  • Fluent in French, professionnal level of English
  • Critical thinking, analytical and problem solving skills. 
  • Demonstrated ability to work autonomously
  • Strong oral and written communication skills and ability to communicate with all levels of management, peers, contractors and external partners effectively
  • Strong organizational skills
  • PC skills and be competent in Word, Excel, PowerPoint and Trackwise

Locations

BEL - Lessines

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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