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 GMP training and documentation manager

Place of work: Belgrade/Vršac/Šabac

About role:

Global GMP training and documentation manager is responsible for establishing, implementing, and maintaining STADA’s Global GMP training program, including related procedures and (electronic) tools as well as guidance, support, reporting and presentation of related topics to Global Quality leadership and global senior management.

Job Description:

QMS/ Documents

• Responsible of creation/implementation, review and improvement of major Global SOPs, such as, but not limited to Global SOP for Document Management and Document Retention, Quality Policy/ Manual
• Contribution to developing, implementing, maintaining and continuously improving Stada Global Quality Management System (QMS) in accordance with EU GMPs and other applicable official regulations and guidelines
• Provides Governance support to Global Quality Leadership, such as, set up system for collection and reporting on applicable QMS KPIs
• Provide required QMS/ Documents support and guidance to Global Quality Leadership
• Prepare and present required presentations and reports to Global Quality Leadership

GMP training

• Maintains and continuously improves the global GMP training process as well as related training assessments/exams
• Develops, maintains and continuously improves required GMP training programs in collaboration with applicable stakeholders
• Ensures direct communication with SVP, QLT, HR and works directly with Clusters
• Develops GMP training curricula and annual training plans for different hierarchy levels in the Tech Ops organization, provides Governance to management for required GMP trainings
• Coordinates and executes global GMP trainingsd
• Identify training gaps and propose appropriate measures
• Development, implementation and reporting of KPIs related to global training process

EDMS

• Global Business Lead for the implementation of a new global electronic document management system (global EDMS)
• Creation/ improvement of EDMS related procedures
• Global Process Owner for the new global EDMS including computerized system validation activities, e.g. URS, DRA, OQ/PQ testing and business required change controls to EDMS

eQMS

• Collaboration with Global Training Process Owner for electronic GMP training tools (eQMS) to assure alignment between Global Training Process and the tool for execution.
• Collaboration with Global Training Process Owner (eQMS) to ensure proper data access for Training KPIs.
• Act as Global Training Coordinator within Global QMS team

Required qualifications:

• University degree in pharmacy, technology, or related field of study
• Minimum 2-3 years of relevant experience in pharmaceutical industry
• Deep understanding of GMP (Good Manufacturing Practice)
• Fluency in English, minimum I-B2 level
• Knowledge of EDMS, eQMS and SAP is preferable
• Proficiency with Microsoft Office

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