Deviation & CAPA Specialist
VALESTA
Mont-Saint-Guibert, Belgium
2 dagen geleden

Job Description

The mission of a Deviation & CAPA Specialist is to create (if necessary), follow up and close the deviations and CAPA across the environment within the company.

You will ensure Quality Oversight on the application of the systems by large and diversified operational area. One of the aims of this mission is to influence the company's standards by active communication with the global functions.

Responsibilities

  • You manage and coordinate activities related to Deviation and CAPA Quality Systems
  • You ensure consistency and communication with the different quality systems and Managers and Global QA CAPA Team
  • You manage and coordinate continuous improvement of Deviations and CAPA Systems and ensure processes are optimized in terms of compliance and efficiency
  • You contribute to the decreased in the number of deviations and CAPA of the unit
  • You manage quality trend analysis, quality reviews on the system
  • You ensure that major issues with an impact on the quality system are captured, followed IP and treated in site action plans
  • Profile

  • You have a University degree in Science (Pharmacist, Engineer or equivalent)
  • You have a former relevant industrial experience or equivalent in pharmaceutical Prod., Validation or QA in a biopharmaceutical
  • You have previous experience in a QA department
  • You have relevant experience in GXP (GMP, )
  • You have a demonstrable influencing ability across departments
  • You have the ability to enable and drive change while being focused on internal and external customers
  • You are fluent in French (both written and spoken)
  • You have good interpersonal relationship skills
  • You are problem-solving and achievement oriented
  • You have a team spirit
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