QA Manager, Responsible Person (RP), Qualified Person (QP)

Novartis

Budapest
Alkalmi
Teljes munkaidő

1 hónapja

About the roleSandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.Join us as a QA Manager, Responsible Person (RP), Qualified Person (QP) of our 'new' Sandoz!Your responsibilities include, but not limited to:

Supervising the work in the warehouse area according to GMP and GDP Guidences in compliance with the local regulations related to the activity;
Performing and inspecting the sampling, sampling control process, qualification, release of registered medicinal products entering the warehouse on the basis of sampling instructions, and in the case of non-compliant products: the locking of these products in the computerized system (SAP);
The acquisition of any missing documents required for release;
Archiving manufacturer release documents;
Send quality certificates electronically signed by the responsible person of Sandoz Hungary Ltd to wholesale partners;
Keeping records of suppliers and customers (regular review);
Approving the change / validation / qualification documents for all significant changes to the marketing process;
Maintaining 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 (stocking);
Initiate and supervise product recall: implement the necessary measures in case of recall and product suspension;
Handling customer complaints and quality complaints;

follow the changes in the regulations affecting his / her field. Prepare and review of quality assurance regulatory documents in the field of regulation of activities related to pharmaceutical wholesale activities;

Participating in professional GMP/GDP trainings and perform GMP/GDP trainings;
Reporting, investigating and document any discrepancies related to the wholesaling and warehousing activity of the medicinal products subject to the Hungarian market;
Performing GDP training for drivers of forwarding companies under contract with Sandoz Hungary Ldt.;
Managing annual self-inspection plan, participate in their implementation; preparation for and active participation in official Authority (NNGYK, Police Department) inspections (especially with regard to controlled drugs), participate in external audits if necessary ;
Handling of formally defective HA permits (so called faulty sample permits), final sample permits, contacting the responsible quality assurance and Regulatory Affairs of Sandoz Hungary Ltd.;
Receipt, inspection, qualification and release of printed packaging materials and concerning units subject of modification with the permission of local NHA (NNGYK). 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;
Archival and disposal of all quality assurance documents (paper and electronic format) in accordance with the rules on archiving;
As Responsible Person (RP) is your responsibility to view the withdrawal / suspension notifications on the NNGYK website at all times. In case of withdrawal / suspension, immediately check whether a medicine has been marketed by Sandoz Hungary Ltd. . At the same time, the Responsible Person (RP) shall view and check the notifications and information on the NNGYK website regarding the faulty sample permissions and the withdrawal of the marketing authorization;
Performance of all other tasks assigned by the immediate supervisor (OPM) in connection with the pharmaceutical wholesale activity;
As Narcotics Responsible Person is solely acting in Sandoz Hungary Ltd. according to the local legal requirements and 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.
Contacting with NHA and Police Department

Place of work:

Sandoz Hungary Ltd. wholesale warehouse (Budaörs)

Role RequirementsWhat you'll bring to the role:

Pharmacy degree
3-5 years' experience gained in similar industry/organizational
Minimum 1 year experience of QP/RP
Healthcare systems thinking
Fluent Hungarian, English at fundamental communication level
Experienced in a matrix organization, collaborating across boundaries

Why Sandoz?Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!The future is ours to shape!Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: https://talentnetwork.novartis.com/sandoztalentpool#SandozFunctional AreaQualityDivisionSANDOZBusiness UnitNON-NVS TSA QUALITY STOEmployment TypeTemporaryCommitment to Diversity & Inclusion:Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.Shift WorkNoEarly TalentYes

Novartis

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