Odborný zástupce velkodistribuce léčiv

Detailní popis produktu

Pro nadnárodní farmaceutickou firmu se sídlem na Slovensku hledáme Odborného zástupce velkodistribuce léčiv. 

Uvedený plat 50 000 Kč je za úvazek 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 in accordance with guideline DIS-13.

- Compliance with reporting obligations concerning the volume of medicinal products placed on the market, in accordance with guideline REG-13.

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

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