AKKA Technologies Company, is an engineering and technology consulting company and supports its clients in meeting their increasing challenges. With more than 20,000 skilled employees and a solid presence in Europe, Asia and America, AKKA Technologies is one of the leaders among European consulting engineering companies, always eager to meet the highest quality standards.
AKKA Switzerland offers proven expertise in the field of life sciences and also active in the field of Information Technologies and Information System.
AKKA Switzerland provides its services throughout the product's entire life cycle (R & D, industrialization, process definition and optimization), and covers Switzerland’s main industrial fields of business: Watchmaking, Aeronautics, Railway, Pharmaceuticals, Medical, Special Machines and Banking.
Description of the project:
- Plan, coordinate and execute all phases for qualification of process equipment, utilities and facilities including but not limited to DQ, IQ, OQ, PQ.
- Prepare, review and approve technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification/validation documentation)
- Coordinate and execute FAT/SAT, commissioning activities for (new) GMP manufacturing utilities/facilities/process equipment in collaboration with internal and external partners
- Coordination and oversight of external subcontractors
- Operational handling of Change Controls, CAPAs and Non-Conformances
- At least 3 years within pharma or a biotech company
- Knowledge of Qualification requirements according to cGMP regulations
- Know-how of quality assurance principles
- Excellent communication skills
- Analytical thinking and problem-solving ability
- Business fluency in English
- German is a plus
To join AKKA Technologies means evolve in the fields you are passionate about in a framework that favors individual initiatives; your role is part of a real business project.