Beschreibung
Quanta Consultancy Services has been asked to support a global pharmaceutical client in the search and selection of an Outsourcing Business Specialist to support its site in Switzerland. This is a very exciting and challenging opportunity, paying competitive rates.Start: Immediately
Duration: Middle of 2015
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 internal team 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 (eg data Matrix, sharepoint, data base infrastructure etc.)
Requirements:
Technical, scientific and/or commercial education (eg 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, etc.) is beneficial
IT knowledge for improving data management is beneficial
Fluent in English, German beneficial.
If you would like to be considered for this fantastic opportunity apply now.