The Lonza is looking for an interested candidate with a flair for both science and IT to join as a Scientific Software Specialist. This position sits within Analytical Services department and is responsible for the management of laboratory scientific software applications in line with regulatory compliance and departmental projects. This is a permanent position based out of Slough facility.
- Laboratory based scientific experience
- Experience of applying knowledge of software compliance and regulatory guidelines from FDA, CFR 21, MHRA and ICH to laboratory software and data management.
- Knowledge of cGMP systems as applied to analytical equipment and testing or experience of working in a highly regulated environment
- Experience in the use of laboratory software packages
- Experience representing software management approaches to internal and external Quality auditors
|Location||Slough, Berkshire (GB)|
- Review and ensure software compliance with respect to 21CFRPart11 and industry best practice, with particular focus on data integrity.
- Lead the strategy for the introduction and development of key IT applications and databases within the Analytical Services laboratories, applications to include inventory & sample management, data acquisition, data storage and archiving, chromatography data system and electronic lab notebook interfaces.
- Represent the department at audit events for software administration and management.
- Lead the approach and maintain the schedule for the periodic assessment of audit trails.
Deadline: Monday, 28 December 2015
Lonza is one of the world’s leading and most-trusted suppliers to the Pharma & Biotech and Specialty Ingredient markets. They harness science and technology to create products that make people’s and animals’ lives healthier and that enhance the overall quality of life and well-being. Their products and services range from active pharmaceutical ingredients and stem-cell therapies to drinking water sanitizers, from industrial preservatives to microbial control solutions that combat dangerous viruses, bacteria and other pathogens, from the manufacture of vitamin B compounds and organic personal care ingredients to agricultural services and products.
The company is organized into two market-focused segments: Pharma & Biotech and Specialty Ingredients. The core competencies that span these segments are advanced manufacturing and quality-control systems, superior regulatory expertise, in-depth market knowledge, and extensive technical customer-support and R&D capabilities