Quality specifications & requirements coordinator
Avantorinc
BEL-Leuven, CH
18 uur geleden

Job Summary

Our VWR sales channel is a one-stop-shop solution provider for laboratories in a wide range of industries : pharma, chemical, universities, healthcare,.

  • from the smallest -but sometimes critical- item until the most complex equipment, we offer a very wide range of products.
  • On top of that, we provide world-class on-site services so our customers can focus on the areas where they have added value.

    We are currently looking for a Quality Specifications and Requirements Coordinator . In this position, you will be responsible for the set-up, supervision and reporting of the quality system for manufacturing, packaging, labeling and distribution of chemical and pharmaceutical products to ensure products and services meet the established standards of quality.

    YOUR RESPONSIBILITIES

  • Interpret and implement quality assurance standards to assure compliance with GMP, ISO 9001, (ISO 13485) and ISO 17025 and industry regulatory requirements.
  • Draft quality assurance policies, procedures, work instructions and supporting documentation in accordance with the VWR International policy, Legal Environmental & Safety regulation, ISO14001 and OHSAS18001.
  • Interact with company management, internal departments, and other sites to effectively implement and maintain Quality Systems and the accompanying document management systems.
  • Evaluate adequacy of quality assurance standards, review the implementation and efficiency of quality and set up inspection systems.
  • Plan, conduct and monitor testing and inspection of materials and products to ensure finished product quality.

  • Devise sampling procedures and directions for recording and reporting quality data. Collect, compile and analyse statistical quality data to identify areas for improvement in the quality system.
  • Prepare reports to communicate outcomes of quality activities.

  • Investigate customer complaints and non-conformance issues
  • Develop, recommend and monitor corrective and preventive actions
  • Identify training needs and organize training interventions to meet quality standards
  • Perform and document internal audits and other quality assurance activities.
  • Coordinate and support on-site audits conducted by third parties and regulatory agency inspections. Evaluate audit / inspection findings and implement appropriate corrective actions.
  • Implement and monitor risk management activities
  • Ensure up to date batch records and support release of GMP licensed products by the Qualified Person.
  • Ensure the calibration of premises and equipment.
  • Regularly communicate with the production team, QA, QC and Supply Chain responsible to identify opportunities for quality and productivity improvement.
  • YOUR PROFILE

  • You have obtained a higher degree in an applied science, engineering field or chemical background.
  • You are fluent in Dutch and English (and French)
  • You have a good understanding of MS Office software, Excel, Word, PowerPoint, Access and SAP
  • WE OFFER

    For this position, we offer a regular full-time employee contract including a competitive salary with meal vouchers, insurance, bonus system and other benefits.

    We will use the personal information that you have submitted to us in order to consider your application for the relevant role.

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