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 Associate (QA)
Place of work: Šabac
Type of contract: Fix termed
About the job
As a Quality Operations Associate (QA), you will play a key role in ensuring high quality standards of products and processes through documentation management and operational quality activities. You will support deviation and complaint investigations, implementation of CAPA measures, compliance with GMP and regulatory requirements, as well as documentation review for batch release and materials management in SAP and LIMS systems, in close collaboration with internal and external stakeholders.
Responsibilities:
- Conduct and monitor activities related to deviation, non-conformity and complaint investigations, CAPA, internal audits, supplier qualification and materials management (raw materials, packaging and finished products).
- Prepare and review technical documentation in line with quality system requirements and GMP standards.
- Monitor regulatory requirements and implement new quality and GMP requirements into existing processes.
- Organise and deliver trainings for employees and provide mentorship for new colleagues.
- Collaborate with internal and external teams, including contract partners and regulatory authorities, and support inspections, validations and annual trainings according to plans and management requirements.
Qualifications:
- University degree in Pharmacy, Technology, Biology, Chemistry or other related technological, pharmaceutical or natural sciences.
- Conversational knowledge of English language.
- Previous experience in quality within the pharmaceutical 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.
Only shortlisted candidates will be contacted.
