Kvalifikovaná osoba pro distribuci - SDP

Detailní popis produktu

Pro nadnárodní farmaceutickou firmu se sídlem na Slovensku hledáme Kvalifikovanou osobu pro distribuci - SDP.. 

Uvedený plat 50 000 Kč při úvazku 15 hodin týdně formou fakturace (OSVČ).

Pozici je možné vykonávat i na dálku z ČR (není zapotřebí působit na Slovensku).

Požadujeme:

• Odbornou způsobilost dle z č. 362/2011  (Zákon o liekoch a zdravotníckych pomôckach) - uchazeč musí být vzděláním farmaceut
• Zkušenost s prací na obdobné pozici 
• Znalost AJ - komunikace probíhá v angličtině
• Nesmí zároveň vykonávat pozici Odborného zástupce pro distribuce léčiv pro jinou farmaceutickou firmu

Job description: 

- Responsible Person (RP) to ensure compliance with EU GDP regulations and relevant national pharmaceutical distribution requirements in Czech.

- Support the implementation, maintenance, and continuous improvement of the company’s Quality Management System (QMS) related to GDP.

- Conduct routine quality checks and audits on storage, transportation, and documentation to ensure compliance with GDP standards.

- Monitor and manage deviations, non-conformances, and complaints, ensuring proper root cause analysis, corrective actions, and preventive measures are implemented.

- Ensure that pharmaceutical products are stored, transported, and handled according to GDP guidelines to prevent damage, contamination, and unauthorized access.

- Maintain proper record-keeping and ensure traceability of medicinal  products through accurate documentation and reporting.

- Participate in and support inspections conducted by regulatory authorities, suppliers, and internal teams.

- Provide training and guidance to staff involved in GDP activities to ensure awareness and adherence to quality and regulatory requirements.

- Carry out supplier and customer qualification and maintain up-to-date documentation related to approved supply chain partners.

- Ensure that temperature-controlled distribution requirements are met,

including monitoring and managing temperature excursions.

- Coordination and execution of all activities related to the recall of medicinal products.

- Decision-making regarding the final disposal of returned, rejected, recalled, or falsified medicinal products.

- Management and resolution of quality-related complaints.

- Maintaining oversight of any GDP relevant subcontracted activities.

- Maintaining oversight of any delegated GDP relevant tasks.

- Compliance with reporting obligations for distributed medicinal products.

- Act as the designated point of contact for GDP-related matters.

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