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.

Quality Operations (QA) Expert Associate
Location: Šabac

About the job:

As a Quality Operations Expert Associate within the System, Compliance and Quality Operations unit, you will have a key role in ensuring high quality standards of products and processes through documentation-related activities. This role includes monitoring, improving and implementing activities related to deviation, nonconformity and complaint investigations, implementation of corrective and preventive actions, regulatory compliance, and execution of global and local standards strategies. You will also be responsible for the review of documentation for batch release to the market, materials management (setting up master data in SAP and LIMS information systems, resolving nonconformities for packaging materials and communication with manufacturers).

Responsibilities:

• Execution and monitoring of activities related to deviation, nonconformity and complaint investigations, CAPA, internal audits, supplier qualification, and materials management (raw materials, packaging materials and finished products)
• Preparation and review of technical documentation in accordance with quality system requirements and GMP standards
• Monitoring of regulations and implementation of new requirements into existing processes
• Organization and delivery of trainings for employees and mentoring of new hires
• Cooperation with internal and external teams, including contract partners and regulatory authorities
• Support in organizing inspections, validations and annual trainings in line with plans and management requirements

Qualifications:

• University degree in Pharmacy, Technology, Biology or Chemistry
• Conversational level of English
• Previous work experience in quality in the pharmaceutical industry or another industry is an advantage
• Knowledge of GMP standards, ISO standards and pharmaceutical industry regulations is an advantage

We offer:

• Private healthcare insurance (with the option of privileged usage for family members)
• Ongoing professional development through specialized education and training
• A platform for learning 14 foreign languages, using various learning styles, including conversation courses
• Personalized mental health and well-being support for employees and their families through the Kyan Health app
• New year bonus 

Only shortlisted candidates will be contacted.