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QA specialist pharma

Long term position at an international pharmaceutical company in Germany!

Job Description

We are looking for an experienced bioprocess engineer to work as a Cell Gene Therapy Specialist in pilot plant under GMP conditions. Your tasks will primarily be focused on QA and documentation of clinical reagent manufacturing batches with USP and DSP techniques.

Responsibility

* QA and documentation (execute and authorize batch records, change controls and deviations) of clinical reagent manufacturing batches.
* Working with USP and DSP techniques and documentation.
* Responsible for the maintenance of clean rooms and monitoring systems.
* Support colleagues of manufacturing and QA when needed.

Profile

* Masters or bachelor's degree in chemical engineering, bioprocess engineering or equivalent with relevant experience in biological processes / analytical development or in support of commercial biological manufacturing processes in a supervisory position.
* Experience with cleanroom equipment and GMP regulated manufacturing environment is required
* Experience in USP, DSP or aseptic techniques is desirable
* Demonstrated ability to work effectively in cross-functional teams, meet deadlines, and prioritize multiple projects
* Attention to detail with excellent communication skills in both verbal and written form.
* Flexibility to work within production deadlines
* English required, German desirable.

Working conditions

* Working Schedule: Full time
* Contract: Through Oxford Global Resource, long term
* Location: Bayern (DE)
* Salary: 85k-90k€ per year
* Vacancy number 18519