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.

IT Quality Process Manager

Place of work: Belgrade

About job:

IT Quality Process Manager is in charge of large-scale Global GxP relevant IT projects, quality initiatives and processes that impact various sectors such as laboratories, production, and global IT systems. They are responsible for the Global Quality Approval and Release of GxP IT System Validations and drive the implementation of a harmonized GxP Computer Validation System governance. Additionally, they provide support for IT validations, influence policy practices, coach team members, and develop strategies for STADA's digitalization and improvements in validation methods.

Key responsibilities:

• Managing large projects / processes independently
• Lead Global GxP relevant IT Projects and Global Quality initiatives which have impact on a large scale of areas (e.g. Laboratories, Production and Global IT Systems)
• Perform Global Quality Approval and Release of GxP relevant IT System Validations
• Main driver to manage, create, implement and maintain harmonized STADA Global GxP Computer Validation System (CSV) Governance
• Policy and strategy implementation for short-term (1 year or less) as well as long-term results (3-5 years)
• Provide support to local, cluster and global teams in IT Validations in compliance with Health Authority requirements
• Influences others outside of own job area regarding policies, practices and procedures
• Coaching, reviewing and delegating work to internal and external professionals involved in projects
• Act as liaison among different stakeholders and Global IT and Quality functional teams
• Develops strategies for STADA digitalization and improvements in new validation methods (Automated Test and digitalized life cycle documents)
• Lead STADA Global GxP relevant IT Projects

Qualifications:

• Diploma in Pharmacy, Natural sciences, Engineering or equivalent, or long-term experience in the pharmaceutical industry

• Minimum 3 years of experience in Pharmaceutical Quality IT role.
• Strong knowledge on GxP and Pharmaceutical Health Authority requirements on Data Integrity, electronic and automated systems, including EU GMP Annex 11
• Strong experience in GAMP principals or similar
• Experience in latest IT developments, including Cloud solutions
• Proven experience in providing training on electronic systems and relevant Quality regulations.
• Experience in Global electronic and automated systems
• Fluent English
• Proactive, self-driven, highly motivated, takes responsibility seriously, cooperative, able to work under pressure
• Good communicator, excellent soft skills
• Ability to structure complex facts in an understandable fashion
• Willingness to travel according to business needs up to 30%

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