QA Operations Specialist (Project)

Job description

Are you ready to help kick start a formulation fill finish plant for the COVID-19 vaccine? We have an interesting project for an experienced QA Operations Specialist who will supervise the start of the production.

Our client is based in Germany, Koln area. For the last year a fill finish plant has been rebuild in order to be able to Fill and Finish Corona vaccines into vials. At this moment, the Process Validation is starting and so is the PV of the production. In order to make sure all Quality requirements are met we are looking for a QA specialist with production knowledge.

Your task include:

  • Oversee the include formulation and filling of the vials along the conveyor belt
  • Manual visual inspection of the vials after each production run
  • AQL sampling and triaging Deviation events
  • Batch review of the production runs
  • General QA overview of the production and give QA instructions to the Operators

In overseeing you will be working in Grade C&D Cleanrooms and the isolator which will take up 25-50% of your time.

Does this sound interesting to you? Then please see if you are a match to the profile;

Job requirements

  • Broad experience as a QA Specialist with knowledge of biopharmaceutical production or Fill Finish
  • Willing to work in 2 shifts and or weekends (details below)
  • Fast learner: you will have to study the methods and pass practical exams including an eye test for inspection of the vials
  • Able to maintain QA standard levels in a rapidly expanding Plant in a startup phase with tight deadlines

You will work in day shift or 2nd shift (e.g. 3pm-11pm) and or 12 hour shift on Saturday and/or Sunday. This is a unique chance to help the world population to be protected from the Coronavirus so if you are available, please step forward now and respond with your CV and short motivation. This role can be either filled as a contractor or an employee. If you have to relocate to the area compensation for B&B will be granted. Estimated time is still unclear but you will start with a 3 -6-month contract with the option to extend.

Apply now and if you are a match we will be in contact within 2 working days.

Please not that this job is open only for EU citizens or you need to be in possession of a valid working permit. Applicants that do not meet these criteria will not be selected.