Banner Image
  • Location

    NOORD BRABANT, Netherlands

  • Job title:

    Quality Assurance Specialist

  • Sector:

  • Job ref:

    45748

  • Start Date:

    2021-04-01

Quality Assurance Specialist 

The company

You will be joining one of the biggest pharmaceutical companies in the world. This site handles secondary packaging, labelling and distribution of the medicine throughout the Europe. 

Description

You will be mainly responsible for providing QA oversight on the supply chain of clinical trial products, QA guidance and support in the production area and clinical product disposition. In this role, you will be in direct contact with a wide range of stakeholders

Responsibilities:

  •  Responsible to provide quality guidance and direction  assuring that cGMP standards are maintained.
  • - Collaborate cross functionally as needed to ensure the Quality Management System processes are executed in accordance with established procedures.
  • -  Perform review, approval and tracking of cGMP processes, procedures, documents and records, including but not limited to SOP`s, Deviations, CAPAs, Change Control records and validation records. May also support execution of these tasks.
  • -  Act as a QA contact for deviations and complaints by participating in investigations, root cause analysis and CAPA`s.
  • - Perform impact assessment as part of change controls impacting production or clinical QA processes.
  • - Assist in the development of GMP and Quality Systems training activities and provides training.
Requirements:
  •  Master’s in science in Pharmacy or equivalent.
  • - Previous experience in a GMP environment.
  • - Thorough knowledge of the processes involved in clinical and commercial manufacturing (GMP), warehousing and supply chain.
  • - Understanding of pharmaceutical development and clinical trial processes is preferred.
Other information:

Are you ready to take a new step in your career? If you are interested or know someone who is, contact me and upload your CV via the apply button
Contact Us

SIRE® LIFE SCIENCES B.V.

Staten Bolwerk 1
2011 MK Haarlem
The Netherlands
+31 (0) 20 658 9800

SIRE® STAFFING SOLUTIONS B.V.

Keizersgracht 440A
1016 GD Amsterdam
+31 (0) 20 658 9804