QA Sterility Assurance
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Hobson Prior are looking for a QA Sterility Assurance to join a fantastic pharmaceutical organisation on a permanent basis. Our client is focused on assisting their clients in developing differentiated, stable solutions.
Please note that to be considered for this role you must have the right to work in this location.
- For this role, you will assume the leadership role in outlining the business's hygiene idea which involves cooperating with the manufacturing division.
- Serve as a QA leader for the disinfectant and pest control programs.
- Evaluate and examine semi-annual trending reports from QC linked to crucial microbiological and chemical/physical process parameters, driving resulting improvements.
- Examine and approve environmental monitoring reports linked to batch release, as well as evaluate regulatory reports for compliance connected to microbiological subjects.
- You will drive the contamination control method in line with annex 1.
- Offer tactical leadership on how to implement and improve aseptic process simulation method as well as verify by evaluating and approving APS protocols and records.
- Responsible for examining and executing improvement actions connected to APS, which involves training operators.
- Outline environmental control method for an ongoing investment project into a new aseptic manufacturing line.
- Accountable QA for QC connected actions like specification and method related document evaluation and approval, review proposal of QC part.
- Educated to a degree level in a microbiology or proven pertinent work experience in microbiology.
- Demonstrable experience in aseptic drug product manufacturing and aseptic process simulations.
- GMP expertise in all pertinent national, EU and US guidelines.
- Experience with deviation and change process.
- Acquaintance within quality control would be beneficial.
- Fluency in both German and English.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
€40000 - €50000 per annum
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