Job type: Contract
Job content
Start date: 01.08.2023
Contract length: 5 months
Capacity: 100%
Responsibilities
• Holds all quality related responsibilities for daily qualification activities on technical facilities, equipment and systems
• Supports the development, reviews and releases qualification documents and GMP design documents
• Assesses and approves change requests with regard to their relevance to the qualified state condition and ensures this supports and approves quality risk analysis (e.g. GMP-FMEA)
• Ensures that deviations are appropriately investigated and addressed in deviation reports processed in deviation reports
• QA activities follow legislation, authority and customer expectations.
• Actively supports the formulation and further development of qualification strategies and continues to training accordingly
Qualifications
• Experience in biotechnology or pharmaceutical environment
• Experience as QA Qualification
• Experience in QA aspects of facility design to build a compliant but cost effective plant (e.g. area classification, CQV requirements etc.)
• Experience of planning and execution of large projects
• Knowledge on FAT/SAT/IQ/OQ/PQ
• You are proactive, with good communication skills and are able to work in a multidisciplinary team towards a common goal.
• You are fluent in English AND German (spoken & written).
Beneficial skills:
Experience in risk analysis
Knowledge of SAP, DMS and TrackWise
Deadline: 13-05-2024
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