Hemofarm is a member of STADA Group, one of the largest global generic pharmaceutical companies, which successfully operates in both the markets of Serbia and Western Balkans. Hemofarm produces high quality pharmaceutical products within the leading pharmacotherapeutic groups, observing the key corporate values: Agility, Integrity, Entrepreneurship and ONE STADA.

Global Quality IT system Expert Associate

Place of work: Belgrade

About job:

Global IT system Expert associate is responsible for establishing and improving the quality management system to ensure compliance of STADA Global electronic systems with applicable GMP and Data Integrity requirements.

Key responsibilities:

• Establish missing and improve existing quality management system to ensure compliance of STADA Global electronic systems with applicable GMPs and Data Integrity requirements
• Support to SAP QM rollout projects
• Provide technical support to internal Stada customers (local sites and affiliates Western Europe) as global SAP key user
• Implementation of new business requirements by customers and authorities
• Quality support to STADA Global SAP System validation
• Create and maintain IT validation related documents e.g., User Requirements (URS) and Testing Plans
• Approve certain user authorizations as role responsible and GxP Approver
• Creation and maintenance of training materials for SAP QM
• Ensure documentation of required training, compliance and user authorizations in system
• Creation and maintenance of plant specific Appendix of Global SOP00013 with validated relevant business cases in cooperation with responsible persons at local sites
• Provide support to other projects such as local LIMS Rollout and validation
• Approve or ensure compliant approval process of Global GxP Validation key documents, including URS, Testing Plans and Change Controls that are governing the GxP relevant IT System Validations

Qualifications:

• Faculty of Pharmacy, Technology or Chemistry or related field of study 
• Active knowledge of the English language – B2 mandatory, C1 level advantage
• Knowledge of SAP, eQMS, EDMS and related it systems is plus
• Advanced level of knowledge of MS Office package
• Excellent communication and organization skills
• Ability to work in a fast-paced, dynamic, environment
• Fast learner and easily adaptable to changes

We offer:

• Continuous learning environment
• Chance for a professional and personal development
• Private health insurance
• Language learning platform for 14 languages with vast type of written and conversational courses
• Personalized mental health and wellbeing support for our employees and their families via Kyan Health application