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.

Global Quality PQR and OGS Expert Associate
Location: Belgrade

Job summary:

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.
 

Your tasks and responsibilities:

Documentation:

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

Evaluation:

• Presenting results; assess trends and determine 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 results / deviations and monitoring of actions defined in the committee

Communication:

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

Process improvement:

• Drives improvements in Quality Documentation and processes

Requirements:

• University degree in pharmacy, biology, chemistry or comparable course of study (f/m/d)
• English language – B2 manatory, C1 level advantage
• Advanced level of knowledge for MS Office package
• Good communication, fast learner and easily adaptable to changes
• Ability to work in a fast-paced, dynamic environment
• Ability to understand and discuss complex topics
• Team-oriented, precise, analytical, responsible
• Availability to travel for team meetings (approx. once per year)

What do we offer:

• Dynamic and responsible position;
• Continuous learning environment;
• Chance for a professional and personal development;
• Good working conditions and positive working atmosphere