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QA-Associate (QA starter)

Leiden
Do you have experience with QC, Method Development or Research within the pharmaceutical industry and ready for your first experience as QA Associate? Then this is thé job for you!

Introductie

Do you have experience with QC, Method Development or Research within the pharmaceutical industry and ready for your first experience as QA Associate? Then this is thé job for you!

Locatie

Leiden

Functie omschrijving

As QA Associate Manufacturing you work to ensure the phase I, phase II and commercial products made meet all the quality requirements: safety, efficacy, potency and purity. This concerns both the requirements from the customer as the regulatory requirements.
You validate that the products comply with the product label claim and maintain the quality system.

As a QA Associate Manufacturing you will:

  • Be responsible for on the floor quality oversight of the production of products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.
  • Work with Project Managers and Operations organization to successfully transfer process from the client to GMP facility to manufacture products.
  • Support drafting of standard operating procedures and batch records.
  • Real time review of all documentation and reporting in support of process unit operations.
  • Ensure non-conformances are investigated thoroughly and approved in a timely manner and appropriate corrective and preventive action plans are implemented.
  • Strive to reduce non-conformances in supported areas by proactively driving compliance.
  • Perform tasks in a manner consistent with the safety policies, quality systems and cGMP

Profiel kandidaat

As QA Associate you like to work in a dynamic environment and your heart beats faster for a great diversity of products. Your excellent communication skills and your strong personality make it easy to connect with the diverse stakeholders in and outside the organisation. You have excellent organisation, facilitating and communication skills. You will need this to be able to carry projects in the organisation and in contact your contact with International Customers. And to harvest quality awareness in the company.

Qualifications:

  • A minimum of a Bachelor’s Degree in Engineering, Science or equivalent technical discipline is required
  • Working experience in clinical quality, QC, method development or Research & Development is preferred
  • Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is required
  • Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing
  • Excellent written and oral communication skills are required

Bedrijfsprofiel

Our client is a GMP accredited contract service organization, specialized in chemical and physical testing and is part of an internationally operating Group. The laboratory performs a very diverse range of analyses of raw materials and end products for a large number of national and international customers within the pharmaceutical industry. In addition to this service, they have a separate Business Unit Manufacturing which specialises in Contract Manufacturing Organisation activities, such as aseptic fill of medication for pre-clinical and phase I and II Clinical Trials. In addition, they also carry out small-scale commercial productions.

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