QC Associate Scientist (m/w/d)

Your tasks:

The job holder is accountable for life cycle management activities of analytical assays performed in the QC

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

• 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)

Your experience/knowledge:

• 1+ years of experience in GMP pharma business activities, preferably in the scope of recombinant therapeutic product in pharmaceutical environment
• Background in GMP Laboratory activities with hands-on experience with statistical tools
• Solid knowledge of method transfer and critical reagent qualification
• Proficiency in all aspects of standard IT tools
• University or engineering degree in analytical chemistry, biotechnology, biochemistry