QC Associate Scientist
CK QLS are recruiting for a QC Associate Scientist to join a Global Pharmaceutical company based in Neuchatel on a contract basis.
Job Responsibilities:
Laboratories of Neuchâtel – Switzerland with a focus on:
• Laboratory Investigations
• Critical Material Qualification
• Laboratory Method Transfers
• Supports daily QC activities following cGMP, company 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
• Support the application of industry specific compliance standards/regulations to assays life cycle management activities
• Participate to daily activities upon request (provide technical and statistical support)
Candidate's Requirements:
• 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