Beschreibung
Quanta Consultancy Services has been asked to support a global pharmaceutical client in the search and selection of a PSC Project Officer to support their site in Switzerland. This is a very exciting and challenging opportunity paying competitive rates.Start: Immediately
Duration: End of 2014
Location: Basel region, Switzerland
This role is to be responsible for evaluations for the business to do tech transfer to 3rd parties or internal sites and also the removal of a product from a site.
All elements have to be reviewed in order to see whether a tech transfer is viable.
Role and Responsibilities:
• Processing of back-log data of pending change requests
• Data cleaning and correction in a new SQL data base
• Monthly preparation of project documentation
• Closing out change requests
• Review new change requests and verify provided data for correctness and consistency
• Data analysis, reporting of change request processing, closure (statistical evaluation)
• Support PSC infrastructure by organisation of schedule, participants, documentation
• Support SQL database improvements
• Ensure all processes are carried out according to GMP regulations
• Support PSC team by taking over specifically defined projects (e.g. data matrix, sharepoint, data base infrastructure etc.)
Requirements:
• Technical, scientific and/or commercial education (e.g. MTA, BTA, Pharmacist, QA, bachelor adequate business fields or equivalent)
• Pharmaceutical knowledge/experience (in areas like development, registration, TechOps, QC/QA)
• Knowledge of Change control requirements (GMP aspects)
• Knowledge to use data systems like SAP, Trackwise (NVS Change Control), SQL databases
• Excellent documentation skills (data verification, data accuracy, data analysis for reporting), detail oriented and accurate
• Drug Regulatory Affairs experience (Generic registration procedures, requirements …) is beneficial
• IT knowledge for improving data management is beneficial
• Fluent in English and German.
If you would like to be considered for this fantastic opportunity apply now.