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 Specialist
Location: Belgrade

Job summary:

As the Global Quality PQR and OGS Specialist, you will be responsible for overseeing and optimizing processes within our organization. Your role will encompass ownership of critical systems, the development and implementation of KPIs to ensure compliance with GMP standards, and the coordination and organization of team tasks to streamline operations.
 

Your tasks and responsibilities:

Documentation:

• Reviewing, evaluating and approving Product Quality Review (PQR) reports and on-going stability reports.
• Responsible for Ordering PQRs and on-going stability reports in the electronic system
• Ownership of systems for archiving of GMP and quality documents

Evaluation:

• Presenting results; assess trends and determine CAPA actions.
• Evaluating 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:

• Key contact for certain topics and worldwide communication with Group-owned production sites and contract manufacturers

Trainings:

• Training of KEY users and end users according to current responsibility matrix

KPIs:

• Maintaining  metrics to ensure correctness, integrity and consistency on (GxP critical) Quality Data

Process Improvement:

• Process owner of the particular process for PQR and OGS Review

Projects:

• Leads and reviews continuous improvement projects and prioritize and lead innovation ideas
• Contributes to global quality project(s) according to agreed project plans

Requirements:

• University degree in pharmacy, biology, chemistry or comparable course of study (f/m/d)
• English language – B2 mandatory, C1 level advantage
• Advanced level of knowledge of MS Office package
• Excellent communication and negotiation skills, Good project management skills, Fast learner and easily adaptable to changes
• Ability to structure complex tasks in a well organized fashion
• Ability to analyze and distribute complex topics, technical writing skills
• Team oriented, proactive, highly motivated, takes responsibility seriously, cooperative, able to work under pressure
• Ability to coordinate cross functional teams
• Minimum 2 years professional experience in the pharmaceutical industry or comparable position, preferably in the field of quality
• Knowledge in continous improvement tools is an added value
   

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