Large Pharma client near Bern Switzerland require an experienced Senior industrial IT CSV consultant for a mission critical project.
The initial contract will be until the end of year, but likely to extend
You will be In charge of Computer System Validation (CSV) activities for Technical Services department in order to ensure that Validation phases are performed according to global and local company policies and procedures as well as legal requirements. Requirements set by regulatory authorities and Validation Master plans are updated and established for all ongoing projects
· Plan, coordinate and execute all phases for computer system validation of production and 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)
· Coordinate and execute FAT/SAT, commissioning activities focused on CSV for new systems in collaboration with internal and external partners
· Ensuring completion of CSV Periodic Review activities and assessment of the required corrective actions
· Validation planning for base business including interaction with IT, Maintenance Automation and Quality Operations groups
· Coordination and oversight of external subcontractors / software suppliers
· 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's degree in technical or natural sciences
· A minimum of 3 years of working experience within Pharma or a Biotech company
Skills / Competences:
Good know-how of CSV requirements according to FDA 21CFR Part11/EU GMP Annex11 regulations and ISPE GAMP5 Guidelines
· Basic know-how of Qualification requirements according to cGMP regulations
· Proven track record of leading and executing CSV validations on manufacturing equipment and higher-level systems (ISA-95 2 and 3)
· Experience on CSV validation for infrastructure systems (e.g.: networkwide services, network infrastructure and virtualization)
· Previous technical experience with IT or automation systems is desired.
· Experience on CSV validation of analytical equipment is a plus.
· Basic know-how of quality assurance principles
· Experience with CAPAs
· Analytical thinking and problem-solving ability
· Communication skills
· Ability to effectively work as part of a multidisciplinary international team
· Time and self-management
· Ability to work under minimal supervision, assess priorities and work well under pressure in a fast-paced environment
· Problem solving skills
· End-to-End project validation delivery thinking required.
· Business fluency in English
· German language preferred
Please call me or forward suitable CVs ASAP