QA Qualification Specialist – 5469 (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 QA Qualification Specialist based in the Visp, Switzerland.
· Holds all quality related responsibilities for daily qualification activities on technical facilities i.e. facilities, equipment and technical systems:
• Supports the development, reviews and releases qualification documents according to the validation master plan.
• Master Plan for process plants
• Approves the qualified process plants
• 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
• Confirms the qualified status of technical equipment and systems during their life cycle by means of regular life cycle by means of regular inspections of their qualification.
· Ensures the following QA activities for these specific areas:
• Follows legislation, authority and customer expectations.
• Informs the Group Manager QA Qualification / Validation about relevant developments and trends and develops proposals to improve or expand existing specifications for these qualification areas.
• Actively supports the formulation and further development of qualification strategies and continues to train accordingly
• Supports internal audits in accordance with the internal audit plan in the function of QA expert (SME)
• QA representative (SME) at customer audits and official inspections
• Supports GMP training programs to ensure that staff are trained; and Supports staff development measures within the QA Group.
Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required.
- Min. 10 years’ experience in Biotech field
- At least one year as QA Qualification
- Knowledge on FAT/SAT/IQ/OQ/PQ and specifically Thermometric Validation
- Fluent in English and German (spoken and written), German is mandatory.
- Knowledge in Warehouse and shipping processes.
- Experience in risk analysis
- Knowledge of SAP, DMS, TrackWise and KNEAT (KNEAT is a big plus)