vacature kwaliteit

International QA Auditor

Derks & Derks

International QA Auditor International QA position / growing company / top service provider in life science and healthcare

Offer
  • a position within a strongly growing, international company
  • diversified job: cooperation with other departments and a lot of different customers
  • international travelling (50%)
  • working for a company with a family culture and a strong team spirit
Organisation

Our client is a global organisation in de field of Supply Chain Services. The company is active in more than 200 countries around the world on a daily basis, and in the Netherlands it is one of the top logistics service providers. In the United States, the healthcare division has acquired a solid market position in de provision of services to companies in the pharmaceutical, medical device and biotech industries. In 2009 the logistics campus of this company started in Limburg, from which the European Healthcare market is further approached. They are growing rapidly: nowadays, they have three different locations and approximately 500 employees in total. Since they will continue to grow, our client is looking for expansion of the healthcare team. Therefore, they are looking for a QA Auditor.

Position

The Healthcare Quality Assurance (QA) Auditor conducts audits of the Healthcare Compliance Distribution locations and supports functions including processes and internal controls. You are responsible for audit preparation, historical trend analysis and risk assessment, execution of the audit, trending of results, and reporting the results to the Sr. QA Management Team and internal customers. You will assist in the management of the overall Global Healthcare Compliance QA Audit Program. In this position you will travel domestically and internationally on a regular basis. Other responsibilities are, amongst others but not limited to: performing internal audits/inspections of Healthcare Distribution Centers, FSLs, and supporting functions within the Global Logistic Distribution Network; reviewing site results and backup to ensure complete and proper documentation is provided; reviewing established controls to verify they are effectively controlling the process; documenting and communicating findings and action plans to provide as reference for Sr. QA Management; and managing the reviews of audit related policies, procedures, regulations, and specific work instructions with internal and external clients to determine specialized requirements and to ensure compliance to the Global Healthcare Compliance Program. You will report to the Senior QA Manager in the United States.

Profile
  • Sc. degree in life sciences (pharmacy or food is preferred)
  • previous experience auditing in GMP/GDP/ISO Healthcare Environment
  • strong understanding and experience working with the various components of Quality Management Systems & GDP/GMP requirements
  • experience with ISO 13485 is an advantage
  • legal, regulatory and compliance knowledge and technical writing skills
  • detail oriented, motivated and takes initiative
  • good knowledge of English; multilingual in Spanish, Portuguese, Polish, Italian and/or Mandarin is an advantage
  • willingness to travel 50-60% within EU, Asia and US
Response

Interested? Please send your resume and motivational letter by e-mail, with reference to WL/18-115-DD, to Djamila Hagemans: info@derksenderks.nl.

For further information, please call Djamila Hagemans at number +31 (0)33 472 80 87.

An individual assessment may be part of the selection procedure.

Our client has chosen Derks & Derks B.V. as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.

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