Hemofarm AD is a member of the STADA group, one of the world's largest generic pharmaceutical companies, which successfully operates in the markets of Serbia and the Western Balkans. Hemofarm produces high-quality pharmaceutical products within the leading pharmacotherapeutic groups, respecting key corporate values: Agility, Integrity, Entrepreneurship and ONE STADA.

Global Quality PQR and OGS Expert Associate

Place of work: Belgrade

Type of contract: Fixed term (maternity cover)

About the job

As the Global Quality PQR and OGS Expert Associate, you will be responsible for ordering, maintaining, and reviewing product quality reviews. You will collaborate with cross-functional teams and external suppliers.

Key responsibilities:

Documentation:

• Reviewing and evaluating of Product Quality Review (PQR) reports and On-going stability reports (OGS).
• Ordering PQRs and OGS in the electronic system.
• Electronic Data Processing (EDP) supported creation, maintenance and archiving of GMP and quality documents.

Evaluation:

• Presenting results; assess trends and determine corrective and preventive action (CAPA actions).
• Participate in the evaluation of out of specification results of batches on the market.
• Support and participation in quality incident committee meetings for risk assessment regarding product quality, especially of batches on the market, in case of above-mentioned OOS (out of specification) results / deviations and monitoring of actions defined in the committe

Communication:

• Worldwide communication with group-owned production sites and contract manufacturers

Process improvement:

• Drives improvements in quality documentation and processes.

Qualifications:

• University degree in pharmacy, biology, chemistry, or comparable course of study
• English language – B2 mandatory, C1 level advantage
• Advanced level of knowledge for MS Office package
• Team-oriented, precise, analytical, responsible
• Availability to travel for team meetings (approx. once per year)

We Offer:

• Private health insurance (with the option of discounted access for family members)
• Continuous professional development through specialized education and training
• Access to a platform for learning 14 foreign languages, with various learning types and conversational courses
• Personalized mental health and well-being support for employees and their families through Kyan.

Only shortlisted candidates will be contacted.