Hands on: Plan, coordinate and execute all phases for computer system validation of production and/or QC Lab systems including but not limited to, Validation plans, FMEA, RTM, DQ, IQ, OQ, PQ test scripts.
Prepare, review, and approve technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification/validation documentation)
Understand customer needs and define electronic records requirements for computerized system adhering to regulation and company standards
Coordinate and execute FAT/SAT, commissioning activities focused on CSV for new systems in collaboration with internal and external partners
Operational handling of Change Controls, CAPAs and Non-Conformances related to CSV Support Technical Services department KPI.
Ensure the CSV process related procedures and life cycle management are up to date according to international GMP standards and internal procedures
Contribute to ensure that changes introduced in the organization of systems, procedures, processes and formulas are managed so that all aspects of the equipment / computerized systems commissioning, and qualification process are assessed and resolved.
Bachelor / Master degree in Life Sciences, biotechnology, chemistry or related filed
Significant experience in computerized system validation (CSV) in a GMP environment
Know-how of CSV requirements according to FDA 21CFR part 11/ EUGMP Annex 11 regulations and ISPE GAMP 5 guidelines
Strong analytical thinking and problem-solving ability
Excellent communication and teamwork skills
Fluent in English and/or German
Multiple options for locations: Bern, Zurich, Basel, Schaffhausen
