CSV Specialist – FinVector Oy, Kuopio8.1.2020
Are you familiar with the abbreviations such as GxP, SOP, SAT, FDA,
GAMP, ERES, and VSR? No? Would you like to know what they mean? We are
looking for a new professional to a Specialist-position in IT team. By
joining us you would soon know the meaning of the abbreviations, and
learn how to work with them. We need a dedicated team player for
Your main responsibilities consist of Coordination/ direction and active participation in the validation of the company Computerized Systems and Software in compliance with company policies, and pharmaceutical regulation. Furthermore, your tasks include developing the validation process for Computerized Systems, and liaising across departments to identify any new systems or processes subject to Computerized System Validation.
Succeeding in your work requires managing preparation of validation Plans, protocols, requirement specifications, and final reports to cGMP standards for Computerized Systems. You would also Lead or participate in Risk Assessments associated with CSV activities. Proven ”hands on” experience on any Computer System Validation is preferred, and if you already know the basics of Requirement Specifications, Testing Methods & Design, and System- and Data Management you are halfway there. You would be the Subject Matter Expert for Computer System validation. We appreciate a precise and systematic way of work and hope that you have an ethos of ’Right First Time’. Your written and spoken English need to be fluent.
The position is full time with normal office hours and flexitime. We would like you to start right away.
We offer you an active and lively work community with highly skilled and experienced personnel in gene therapy manufacturing. Working with us, you are entitled to good employment benefits, such as extensive occupational health-care, and we support your physical and cultural free-time activities. We provide you wide initial training and a warm welcome. FinVector is located in vibrant Kuopio, which is rated as Finland’s best city to live in. It offers a safe living environment, friendly atmosphere and clean nature.
Please send your application with salary request and CV in English by 31 January 2020.
Yhteystiedot More information about the position can be asked from IT Manager Jari Huttunen, p. 040 173 8061 on Friday 3 January at 14-16 or Monday 13 January.
Työpaikan osoite Microkatu 1 S, 70210 KUOPIO
Työ alkaa mahdollisimman pian
Työn kesto yli 12 kuukautta, toistaiseksi voimassa oleva
Haku päättyy 31.01.2020 klo 23:59
Ilmoitus jätetty 30.12.2019