Quality Engineering Specialist (LZAJP00004362)
Key Responsibilities:
- Holds all quality related responsibilities for daily qualification activities on technical facilities, equipment and systems
- Supports the development, reviews and releases qualification documents.
- Approves applicable qualification 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.
- Informs the Group Manager QA Qualification about relevant developments and trend
- Actively supports the formulation and further development of qualification strategies and continues to training accordingly
- Supports internal audits in accordance with the internal audit plan, at customer audits and official inspections as QA representative (SME)
Key Requirements:
- Experience in biotechnology or pharmaceutical environment
- Experience as QA Qualification
- 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.
- Beneficial skills: risk analysis, Knowledge of SAP, DMS and TrackWise
À propos de l'entreprise
