Jun 10, 2022

Job Description

1! Sandoz is the number one generic company in Hungary, and this is your opportunity to join us as the GDP Manager, Responsible Person. In this role you will release Novartis and Sandoz medicinal products according to the GDP regulations, you will view the final sample/ withdrawal / suspension notifications on the OGYÉI website at all times. As Narcotics Responsible Person you will be solely acting in Sandoz Hungary Ltd. according to the local legal requirements and be responsible for governance of the procurement and distribution of Controlled Drugs (narcotic and psychotropic products), handling narcotics product related documents and informing the authorities by preparing and issuing the necessary controlled drug quarterly and annual reports.

Your Key Responsibilities:
Your responsibilities include, but not limited to:
• Quality oversight the work in the Novartis and Sandoz warehouse area according to GMP and GDP Guidance in compliance with the local regulations related to the activity
• Inspect the sampling, sampling control process, qualification, release of registered medicinal products entering the warehouse based on sampling instructions and regulatory requirements, and in the case of non-compliant products: the locking of these products in the computerized system (SAP)
• Manage quality certificates electronically signed by the responsible person of Sandoz Hungary Ltd / Novartis Hungary Ltd. to send to wholesale partners; keep records of suppliers and customers and regularly review them; approve the change / validation / qualification documents for all significant changes to the marketing process
• Maintain appropriate documentation and use of the reading devices and checking of the temperature recorders (data loggers) applied during delivery and wholesale in-and out-bounding; initiate and supervise product recall: implement necessary measures in case of recall and product suspension; handle customer complaints and quality complaints
• Follow the changes in the regulations affecting respective field. Prepare and review quality assurance regulatory documents in the field of regulation of activities related to pharmaceutical wholesale activities; participate in professional GMP/GDP trainings and perform GMP/GDP trainings
• Report, investigate and document any discrepancies related to the wholesaling and warehousing activity of the medicinal products subject to the Hungarian market; handle customer complaints and quality complaints in collaboration with Complaint Hub Slovenia as first contact for the Hungarian market.
• Manage annual self-inspection plan, participate in their implementation; preparation for and active participation in official Authorities (e.g., OGYÉI) inspections (especially with regard to controlled drugs), participate in external audits if necessary
• Handle formally defective HA permits (so called faulty sample permits), final sample permits, contact the responsible quality assurance and Regulatory Affairs of Sandoz Hungary Ltd. and Novartis Hungary Ltd.; receive, inspect, qualify and release printed packaging materials and concerning units subject of modification with the permission of OGYÉI. Approve the packaging order of these preparations to be modified - review of the packaging documentation, control of the repacked/modified units and their packaging material provided by our third-party packaging plant.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:
• Degree in Pharmacy
• 3-5years experience in Pharma wholesaler sector in a GMP/GDP environment
• Operations Management and Execution experience
• Fluent Hungarian and Intermediate level English
• Knowledge of Good Documentation and Good Distribution practice, Inspection preparations, CAPA, GMP, Product release and Quality control

Desirable Requirements:
• Good communication skills in strictly controlled environment
• Responsible Person and/ or Narcotics Responsible Person

Why consider Sandoz?
500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Sandoz!

Imagine what you could do at Sandoz!

Commitment to Diversity & Inclusion:
Sandoz, a Novartis company, embraces diversity, equal opportunity, and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Sandoz are an equal opportunities employer and welcome applications from all suitably qualified persons.

Join our Novartis Group Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

We are Sandoz, a Novartis Division. Join us and help reimagine medicine.
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Novartis Technical Operations
Full Time
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GDP Manager - Responsible Person

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