QA Engineer

We are SIMABS

SIMABS is a biotechnology venture that provides cost effective therapeutic monoclonal antibodies to biopharmaceutical companies. We are hiring a QA Engineer who has a startup vibe to join our small team. Be part of our mission and set the new standard in biopharmaceutical manufacturing technology. Our values are KISS: Keep It Simple & Smart, Innovate the process and last but not least, Enjoy the flow.

Job content

As our QA Engineer, you will combine project QA tasks, routine QA tasks, as well as maintenance of the Quality Management System (QMS) within the company .

Responsibilities:

• Project QA

  • Support implementation of new products at our GMP site

  • Discuss and review tech transfer data packages and implementation documents

  • Write and review project specific validation protocols & reports

• Routine QA 

  • Issue master batch records and conduct batch record review

  • Support and review of Environmental monitoring activities

  • Release incoming materials and write material specifications

  • Assist in supplier qualification and requalification

  • Ensure QA oversight on Good Documentation Practices and Good Manufacturing Practices

• Maintain the (electronic) Quality Management System

  • Review & follow-up of events, planned deviations, supplier complaints, OOS, CAPA, and change requests

  • Write and review SOPs, work instructions and forms

  • Archive records and files

  • Prepare management review documentation

  • You work closely together with the head of quality

• You engage in a broad range of activities in order to grow simAbs into a strong and reliable partner for future clients.

Requirements

Education:

Master Degree in Biochemistry, Chemistry, Pharmaceutical Lab Technology or equivalent through relevant experience. Ideally you already have +/- 3 to 5 years of working experience in a GMP environment.

Competences:

Technical skills:

• Skilled in GMP and Good Documentation Practices

Soft skills:

• Quality minded

• · High degree of accuracy, well organized and result oriented team player

• Fast assembly of new information

• Swift learning on the job

• Strong and honest communicator

• Flexible both in content as in time (occasional working during the weekend, early morning, evening or night)

• Enjoying the start-up flow of our organization

Do you want to share our passion in creating sustainable biomanufacturing solutions?

Apply by sending us your cv to job.4uwhe@simabs.recruitee.com