Senior Quality Assurance Specialist – 5377 (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 Senior 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