Qc Associate Scientist
vor 5 Monaten
START DATE: April 1st
DURATION: 6 mois
Location: Neuchatel
Workload: 100% (40%remote, 60%onsite)
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, Takeda 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
Investigation 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
assays life cycle management activities
- Participate to daily activities upon request (provide technical and statistical
support)
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
Competencies
- 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
- Effective communicator
- Demonstrated ability to synthesize information
- Demonstrated ability to give and receive feedback
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