Quality Assurance Specialist – 5467 (ADA)
Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a Quality Assurance Specialist based in the Visp, Switzerland.
• 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)
Qualifications and Experience:
• Relevant working/residency permit or Swiss/EU-Citizenship required.
• 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 would be advantageous
• Experience in risk analysis
• Knowledge of SAP, DMS and TrackWise