We are looking for a Quality SGIE Specialist and Senior Quality SGIE Specialist in Visp. This role is temporary and for a minimum of 7 months.
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 according to the validation master plan - 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 - Informs the Group Manager QA Qualification / Validation about relevant developments and trends - 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)
- 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 - Fluency in English (spoken and written), German a plus - Experience in risk analysis is preferable - Knowledge of SAP, DMS and TrackWise is a plus