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 Expert Associate (QA)
Place of work: Sabac

About the job:

As a Quality Operations Expert Associate within the Quality Systems, Compliance and Quality Operations unit, you will play a key role in ensuring high standards of product and process quality through documentation-related activities. This position involves monitoring, improving, and implementing activities related to deviation investigations, non-conformities and complaints management, implementation of corrective and preventive actions (CAPA), regulatory compliance, and execution of global and local quality standards strategies. In addition, you will be responsible for reviewing batch release documentation, managing materials (including master data maintenance in SAP and LIMS systems), handling packaging material non-conformities, and communicating with manufacturers.

Responsibilities:

• Perform and monitor activities related to deviation investigations, non-conformities, complaints, CAPA management, internal audits, supplier qualification, and material management (raw materials, packaging materials, and finished products).
• Prepare and review technical documentation in accordance with Quality Management System requirements and GMP standards.
• Monitor regulatory requirements and implement new requirements into existing processes.
• Organize and conduct employee training sessions and provide mentoring support to new employees.
• Collaborate with internal and external stakeholders, including contract partners and regulatory authorities.
• Support the organization of inspections, validations, and annual training activities in line with plans and management requirements.

Qualifications:

• Bachelor education degree in Pharmaceutical Sciences, Technology, or another Natural Sciences field.
• Previous experience in Quality Assurance or Quality Operations within the pharmaceutical industry is considered an advantage.
• Good command of the English language.
• Knowledge of GMP standards, ISO standards, and pharmaceutical industry regulations is considered 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.