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Qc associate scientist / ta-330

Neuenburg
SimplyVision GmbH
EUR 30’000 - EUR 80’000 pro Jahr
Inserat online seit: 12 Juni
Beschreibung

For our customer located in Neuchatel / Switzerland we are currently looking for a : QC Associate Scientist (m / f / d)

Tasks & Responsibilities

Duties

The job holder is accountable for life cycle management activities of analytical assays performed in the QC Laboratories of Neuchâtel – Switzerland with a focus on :

* Laboratory Investigations
* Critical Material Qualification
* Laboratory Method Transfers

In addition, the job holder also supports daily QC activities following cGMP, Pharma policies and EHS requirements.

Validation and Qualification Activities

* Author transfer protocols and reports for assays
* Author qualification plans and reports for critical reagents
* Oversee validation and qualification activities executed by analysts, provide training and support
* Execute and documents experiments

I nvestigation Leads

* Investigate and trouble shoot problems which occur to determine solutions or recommendations for improvements or change
* Conduct / participate in risk assessments, root cause analysis and investigations
* Own Laboratory Investigations and CAPA

Quality Control Support Activities

* Support the application of industry specific compliance standards / regulations to assays life cycle management activitiesParticipate to daily activities upon request (provide technical and statistical support)

Must Haves

Experience

* University or engineering degree in analytical chemistry, biotechnology, biochemistry
* 1 or 2 years of experience in GMP pharma business activities, preferably in the scope of recombinant therapeutic product in pharmaceutical environment
* Experience in GMP Laboratory activities
* Good knowledge of method transfer
* Good knowledge of critical reagent qualification
* Experience in problem solving and deviation management
* Good Knowledge of statistical tools
* Fluent in French and English (C1 written and spoken)
* Proficiency in all aspects of standard IT tools
* Excellent collaboration skills and teamwork mindset
* Good trouble shooting and problem-solving skills
* Ability to work independently in a fast-paced environment
* Ability to manage multiple priorities and know when to escalate issues for resolution
* Demonstrated ability to synthesize information
* Demonstrated ability to give and receive feedback
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