QUALITY SPECIALIST | BUCHAREST | SECTOR 1 | HYBRID

Key responsibilities:

  • Acts as back-up for the Responsible Person (RP), ensuring continuity of regulatory and quality activities;
  • Ensures the implementation, maintenance, and continuous improvement of the company’s Quality Management System (QMS);
  • Oversees the implementation and compliance with Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP) guidelines;
  • Provides support to the Marketing Department in the process of granting free medical samples, ensuring compliance with applicable regulations;
  • Responsible for the qualification and periodic re-qualification of suppliers and customers;
  • Evaluates products affected by temperature excursions and other deviations, ensuring proper documentation and disposition;
  • Acts as back-up Responsible Person in case of product recalls, supporting recall coordination activities;
  • Represents the wholesale distribution unit in interactions with relevant regulatory and professional authorities;
  • Participates in Change Control processes and repackaging activities, ensuring compliance with internal and regulatory requirements;
  • Prepares and maintains documentation required for obtaining and updating the wholesale distribution authorization; initiates re-authorization processes when necessary;
  • Participates in internal audits, audits of logistics service providers, and inspections conducted by competent authorities;
  • Manages customer complaints by ensuring timely registration, investigation, sample handling, and communication of results within established timelines;
  • For new products, ensures accurate and complete data transmission to the logistics service provider (e.g. product details, pricing, regulatory codes, storage conditions);
  • Collaborates with the Responsible Person in reviewing and updating SOPs, acting as content owner where applicable.

 

General skills/experiences needed for the job:

  • Bachelor's degree in Pharmacy;
  • Advanced English level (written and spoken);
  • Familiarity with quality management systems and regulatory requirements;
  • Strong analytical thinking and attention to detail;
  • Excellent organizational and time management skills;
  • Effective communication and teamwork abilities;
  • Proficiency in Microsoft Office (Word, Excel, PowerPoint).

 

Other information:

  • The recruitment process will be conducted through QPAS.
  • Only eligible candidates will be contacted.

 

Attention:

  • By applying to this job, we are deemed to have your default consent to the processing of personal data by QPAS, pursuant to Regulation (EU) 2016/679.

 

 

 

 

 

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