IT QM & Serialization team
About us:
IT QM & Serialization team is providing IT support to the whole STADA group in designated areas.
We are collecting, defining and documenting business and technology requirements, designing the concept of IT solutions, implement and validate them in GMP conform environments.
Producing medicines and other health care products requires highest set of pharmaceutical standards, with precision that technology and software can provide. We take care of the software.
Interesting facts about us:
• We have in the team consultants from 2 – 20 years of experience in pharma industry
• We have blood donors in the team
• Everyone enjoys outdoors (hiking, skiing, water activities)
• We love to have off-work topic team meetings
(such as: Online presentation of favorite drink, food, pet; Online gaming night; Onsite barbeque)
Serialization
IT is ensuring legal compliance for Serialization regulatory initiatives worldwide in pharma industry.
The mail goal of Serialization is to prevent falsification of medicines and selling of falsified goods, hence, to protect the patients.
(All produced goods must be marked with unique identifier, so called ‘serial number’ and reported to state national systems, otherwise it is not possible to sell the goods on the markets)
Projects:
• EU FMD legislation (European Union Falsified Medicine Directive)
• Track&Trace Russia
• Serialization Saudi Arabia
• Track&Trace Kazakhstan
Quality Management
Quality management area is essential for ensuring that pharmaceutical products are manufactured to a safe and consistent standard using procedures such as laboratory testing, batch inspection, audits, investigations, change control, etc.
IT is providing qualified systems and support for all QM business processes.
Projects:
• Global LIMS (Laboratory information management system)
• SAP ERP rollouts
• OPV (Ongoing process verification)
• eQMS (Electronic quality management system)