PlusOne

QA Associate - Life Sciences - Gosselies

Company

Our client is a high-potential CRO based in Gosselies, Belgium. This fast-growing company offers a wide range of Immunology services with a strong commitment to develop customized solutions for its clients. The offerings include in vitro assays to assess the immunogenic potential of test molecules using T cell activation and proliferation assays as a surrogate marker for the induction of Anti-Drug[1]Antibodies. On the immuno-oncology side, our client develops in vitro assays to assess the functionality of candidates. They continuously develops new cellular immunoassays to assist biotech and pharma companies directly in their product development. Other such collaborative services include protocol optimization and in-house training. Our client’s team works in an open-minded, science-driven and fast-paced environment. In order to support their growth, they are actively looking for to fill the following role:

Role

As R&D QA Associate, you will work closely with the Director of Operations to set-up a quality management system tailored to the needs of the company. You will collaborate internally with the scientific teams to ensure a slow yet steady shift of mindsets towards GLP-like quality standards.

Your responsibilities

Main focus of the role is to build an operational excellence culture within the company, notably by setting up a quality management system tailored to the needs.

  • This will include among other things:
  • Create a job description per function, matching the company’s organigram
  • Build a training matrix for each R&D function and ensure implementation
  • Develop a SOP management system and ensure implementation;
  • Set-up an equipment management strategy, make sure lab equipment’s are maintained as needed and review service reports;
  • Closely follow the implementation of new worksheets/batch records;
  • Participate in writing/review of SOPs
  • Quality review and audit R&D data records, focusing on data quality and integrity;
  • Take part in audit from customer and follow-up implementation of corrective actions
  • Be involved in identifying quality processes that need to be improved and develop strategies with the team focusing on increased quality and traceability.

Profile

Requirements

Scientific degree in Bioengineering/Industrial Pharmacy/Biomedical Sciences or equivalent

  • Minimum 3-5 years of relevant experience
  • Experience with setting up QA tools (tracking, record) is highly desired
  • Knowledge of ISO 9001 is a plus
  • Previous experience within a QA function is a plus
  • Good knowledge of Offices suite including Excel and Access.
  • Experience working with customers and service providers is a plus
  • Excellent knowledge of English and French

Skills and competencies

Deliver results and is committed to achieve challenging objectives

  • Strong ability to work in team
  • Strong negotiation skills & influential capabilities
  • Excellent communicator
  • Creative, thinking outside the box
  • Demonstrated knowledge of quality systems
  • Works precisely as per procedures, rules and regulations
  • Comfortable in multi-tasking
  • Responsible and integer

Publication date

27.04.2021

Contact person

Leonard

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