ZENTIVA INTERNATIONAL A.S. HLOHOVEC SUCURSALA BUCURESTI
Bucureşti Sectorul 3, B-dul THEODOR PALLADY, Nr. 50, CLĂDIRE ADMINISTRAŢIE, ZONA B, BIROUL NR. 1, Etaj 3
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Managing the stock level for Raw/Packaging Materials in accordance with the production plan requirements;
Launch purchase orders and follow up till their receipt in Zentiva site, check documents and prices. Operating orders in SAP and updating allocated articles and vendors parameters. Grant support for qualitative/ quantitative/documentary complaints if any and sustain company QA auditors with data related to allocated suppliers;
Generating and administrating of specific reports (write-offs, inventory level, stock cover);
Managing the inventory projection, taking decisions to postpone/cancel orders in order to be in line with inventory target;
Managing Master Data cleaning on quarterly basis for entire operational procurement portfolio and keep correct master data settings (lead-time, MOQ, safety stocks etc) for his portfolio;
Involvement in projects related to the area of activity
On monthly basis, is analyzing the provision report and is mitigating the risk of write-off for the materials in his portfolio;
Ensure timely request for import licenses to Qualified Person in order to assure in proper time the special substances supply
Constant communication and follow up with allocated suppliers and the new ones according to internal projects
Participation in internal periodical or punctual meetings together with other involved departments to update ongoing projects status (research and development projects, optimization projects or technological transfers, strategic procurement operational meeting, material availability meeting, etc.)
Este responsabil de desfășurarea activității de instruire periodică din departamentul FSD pentru toate categoriile de personal în conformitate cu Programul anual de instruire (planificare instruiri, pregătire materiale, organizarea și susținerea activității de instruire)
Desfașoară interviuri cu candidați pe teren în vederea angajării de noi operatori
Urmărește și asigură suport colegilor nou angajați pe perioada procesului de inducție și mentorat
Elaborează Programe de instruire RBPF, cu tematici specifice locurilor de muncă pentru personalul nou angajat (operatori producție farmaceutică&șefi de schimb)
Realizează și înregistrează instruirea teoretică a personalului nou angajat (operatori producție farmaceutică & șefi de schimb), cu tematici specifice locurilor de muncă conform Programelor de instruire RBPF din departamentul : FSD
Realizează evaluarea chestionarelor de evaluare a cunoștințelor personalului nou angajat
Monitorizează perioada de mentorat a noilor angajați pentru a se asigura de buna desfășurare a procesului
Acordă suport mentorilor
Identifică noi nevoi de instruire/calificare pentru personalul din departament
Elaborează/revizuiește documente ale sistemului calității în departament (PSO/IL)
Participa la inspecţiile şi auditurile interne pe fluxurile de fabricaţie şi depozitare şi/sau externe în vederea asigurarii respectarii legislaţiei în vigoare şi a normelor GXP;
Stabileşte şi urmareşte împreuna cu auditatul acţiunile şi termenele asumate în urma desfaşurarii auditurilor interne si externe;
Evalueaza zonele auditate/inspectate în conformitate cu normele GXP prin completare de rapoarte specifice;
Investigheaza deviaţiile şi monitorizeaza acţiunile corective şi preventive pentru departamentul dedicat din cadrul zonelor cu impact în fabricaţia / testarea produsului medicamentos;
Investigheaza sau participa la investigarea rezultatelor OOS/OOT aparute in fabricatia de rutina sau in cadrul programului de testare a stabilitatii
Este responsabil de procese specifice asigurarii calitaţii alocate ca arie de responsabilitate/departamente
Verifica şi avizeaza documentaţia corespunzatoare activitaţii pentru departamentele dedicate din cadrul zonelor cu impact în fabricaţia produsului medicamentos (proceduri şi instrucţiuni de lucru)
Efectueaza analize de risc si participa la identificarea actiunilor necesare reducerii riscurilor din zonele de fabricatie GMP
Monitorizeaza planul de audit intern si extern precum si asigura support in actualizarea statusului in accord cu planul
Perform the monthly MPS process, ensure a clear and correct stock cover report, schedule the production plan for all the transfers portfolio and lead the production planning scheduling for the regular portfolio;
Ensure an optimal stock cover for the entire portfolio, maintaining the quarterly/yearly inventory target;
Balancing in a correct way the production planning capacity for the entire manufacturing/packaging process, for at least 12 months horizon;
Have a clear control over all artwork changes for printed packaging materials, minimize as much as possible all potential write-offs, by implementing the change at the right moment in time;
Track all materials missing alerts which can generate impact in production plan, twice / month;
Make sure that all master data related to planning is correctly set into the system;
Ensure the successful introduction of the portfolio of all new products from planning perspective, until the product is completely transferred in our production site;
Being the single point of contact from planning for all new transferred products, monitor the timeline of transfer date, create a correct planning sequence of the first transferred volumes;
Monitor & report all required data from planning perspective: production volumes, market inventory level, all other KPIs;
Being part in all budget exercises, make sure all products are well balanced from stock cover perspective;
To build trust, motivate the team members and provide a real support in their daily activities;
Fast decision making, ability to create complex analysis, ability to work together with the team on specific tasks
Attract and retain great people; Know each individual’s capabilities and aspirations; Invest in the growth of others
Able to define team objectives and outcomes, help the team adapt and learn
Nurture and role model a culture of learning, driving results as One team
With support from the local&global team; Successfully execute:
The Transportation Roadmap globally.
The global and regional improvement projects assist in the delivery of regional elements of global projects
The Transportation Roadmap globally
The global and regional improvement projects assist in the delivery of regional elements of global projects
Manage the dispatching and tracking/monitoring of all transportation activities
Monitor the general operations of the transportation department to ensure that the Zentiva is operating within EU regulatory guidelines, local legislation, and administrative policies and procedures
Develop growth scenarios of improvement in the management of transportation and implement solutions of constant cost-effective transport solutions. Work with cross-function teams to develop the logistic network and reduce the efficiency of drainers
Conduct necessary investigation(s) utilizing the company’s quality management software (Trackwise) in determining the root cause/s of problems associated with transport shipments and propose effective CAPA (corrective actions and preventative actions) to correct and avoid recurrence
Maintain an open dialogue with other units’ managers to organize activities that will enhance the company’s general performance
Ensure that customer complaints with regards to product delivery and other transportation-associated issues are logged and tracked through to completion in the company’s complaint management system (Trackwise)
Support negotiation and authorization of contracts and other forms of purchases and procurements that are related to the company’s transportation needs. Lead local initiatives and manage the contracts in accordance
Develop important indicators (KPIs) that measure and show the effectiveness of the company’s transportation operations
Develop transportation policies across appropriate units within the organization
Support in the negotiation with third-party warehouse providers and carriers for their services and for competitive rates. Take the lead in case of a specific set-up not included in Global management
Implement management recommendations, like proposed fees and change in loading plan with the effect of CSL, inventory, cost efficiency, makes recommendations and scenarios to support the decision-making process
Managing the stock level for Raw/Packaging Materials in accordance with the production plan requirements;
Launch purchase orders and follow up till their receipt in Zentiva site, check documents and prices. Operating orders in SAP and updating allocated articles and vendors parameters. Grant support for qualitative/ quantitative/documentary complaints if any and sustain company QA auditors with data related to allocated suppliers
Generating and administrating of specific reports (write-offs, inventory level, stock cover)
Involvement in projects related to the area of activity
Ensure timely request for import licenses to Qualified Person in order to assure in proper time the special substances supply
Constant communication and follow up with allocated suppliers and the new ones according to internal projects
Participation in internal periodical or punctual meetings together with other involved departments to update ongoing projects status (research and development projects, optimization projects or technological transfers, strategic procurement operational meeting, material availability meeting, etc.)
Has the responsibility of GMP compliance on all SC processes and is part of the Authority inspections for the SC processes (MPS Planning, Master Data, Operational Procurement, Customer Service, Warehouses)
Perform the monthly MPS process, ensure a clear and correct stock cover report, schedule the production plan for all the transfers portfolio and lead the production planning scheduling for the regular portfolio;
Ensure an optimal stock cover for the entire portfolio, maintaining the quarterly/yearly inventory target;
Balancing in a correct way the production planning capacity for the entire manufacturing/packaging process, for at least 12 months horizon;
Have a clear control over all artwork changes for printed packaging materials, minimize as much as possible all potential write-offs, by implementing the change at the right moment in time;
Track all materials missing alerts which can generate impact in production plan, twice / month;
Make sure that all master data related to planning is correctly set into the system;
Ensure the successful introduction of the portfolio of all new products from planning perspective, until the product is completely transferred in our production site;
Being the single point of contact from planning for all new transferred products, monitor the timeline of transfer date, create a correct planning sequence of the first transferred volumes;
Monitor & report all required data from planning perspective: production volumes, market inventory level, all other KPIs;
Being part in all budget exercises, make sure all products are well balanced from stock cover perspective;
To build trust, motivate the team members and provide a real support in their daily activities;
Fast decision making, ability to create complex analysis, ability to work together with the team on specific tasks
Inregistrara in sistemul informatic SAP si verificarea reflectarii corecte in contabilitate si la timp, in conformitate cu reglemantarile in vigoare si regulile interne a urmatoarelor operatiuni:
Verificarea/ operarea bazei de furnizori interni/ externi;
Operarea si verificarea inregistrarilor privind achizitiilor interne, intracomunitare si importuri;
Operarea si verificarea inregistrarilor referitoare la achizitiilor de servicii interne si externe - prin aplicarea conventiei de evitare a dublei impuneri, unde este cazul;
Verificarea si reconcilierea raportelor din SAP cu situatiile analitice si detaliile primite de la parteneri;
Reconciliere/validare declaratiei Intrastat cu jurnalele de achizitii si vanzari;
Operarea si gestionarea registrelor de mijloace fixe, reconciliere cu balanta analitica – capitalizari, iesiri, evaluari in SAP ;
Evidenta inregistrarilor si scadentarul pentru achizitiile de leasing- inclusiv IFRS 16;
Monitorizarea accrual-urilor pentru inchiderile lunare inregistrate in contabilitate (evalueaza mentinerea accrualurilor anterioare, pregatire accrualuri noi)
Analizeaza reconcilierii cu balanta a creantelor; datoriilor; stocurilor;
Suport pregatirea raportarii SAF T
Asista si pregateste informatii pentru auditul financiar intern si extern;
Participarea la inventariere anuala a patrimoniului;
Respects, checks and trains subordinate personnel;
Responsible for carrying out the production activity, under maximum security conditions;
Coordinates the quality system implementation activity within the Dosed Solid Forms department, according to .;
Develops the quality system documents on the production flow of the Solid Dosage Forms preparation department;
Approves the procedures and work instructions regarding product operations and guarantees their strict application;
Coordinates and organizes the production activity of Solid Form Preparation-Processing so as to ensure compliance and fulfillment of the production plan;
Identifies the critical parameters and controls in the processes necessary to control the manufacturing process;
Involved in the activity of investigating deviations from the RBPF norms and from the procedures in force;
Ensures the implementation of the established corrective and preventive actions;
Knows, analyzes and monitors the technical and economic problems that arise at the level of the Solid Dosage Forms-Processing Department;
Defines, delegates clear responsibilities and objectives to subordinates;
Performs evaluation, development and motivation of coordinated employees ;
Este responsabil de desfășurarea activității de instruire periodică din departamentul FSD pentru toate categoriile de personal în conformitate cu Programul anual de instruire (planificare instruiri, pregătire materiale, organizarea și susținerea activității de instruire)
Desfașoară interviuri cu candidați pe teren în vederea angajării de noi operatori
Urmărește și asigură suport colegilor nou angajați pe perioada procesului de inducție și mentorat
Elaborează Programe de instruire RBPF, cu tematici specifice locurilor de muncă pentru personalul nou angajat (operatori producție farmaceutică&șefi de schimb)
Realizează și înregistrează instruirea teoretică a personalului nou angajat (operatori producție farmaceutică & șefi de schimb), cu tematici specifice locurilor de muncă conform Programelor de instruire RBPF din departamentul : FSD
Realizează evaluarea chestionarelor de evaluare a cunoștințelor personalului nou angajat
Monitorizează perioada de mentorat a noilor angajați pentru a se asigura de buna desfășurare a procesului
Acordă suport mentorilor
Identifică noi nevoi de instruire/calificare pentru personalul din departament
Elaborează/revizuiește documente ale sistemului calității în departament (PSO/IL)
Attract and retain great people; Know each individual’s capabilities and aspirations; Invest in the growth of others
Able to define team objectives and outcomes, help the team adapt and learn
Nurture and role model a culture of learning, driving results as One team
With support from the local&global team; Successfully execute:
The Transportation Roadmap globally.
The global and regional improvement projects assist in the delivery of regional elements of global projects
The Transportation Roadmap globally
The global and regional improvement projects assist in the delivery of regional elements of global projects
Manage the dispatching and tracking/monitoring of all transportation activities
Monitor the general operations of the transportation department to ensure that the Zentiva is operating within EU regulatory guidelines, local legislation, and administrative policies and procedures
Develop growth scenarios of improvement in the management of transportation and implement solutions of constant cost-effective transport solutions. Work with cross-function teams to develop the logistic network and reduce the efficiency of drainers
Conduct necessary investigation(s) utilizing the company’s quality management software (Trackwise) in determining the root cause/s of problems associated with transport shipments and propose effective CAPA (corrective actions and preventative actions) to correct and avoid recurrence
Maintain an open dialogue with other units’ managers to organize activities that will enhance the company’s general performance
Ensure that customer complaints with regards to product delivery and other transportation-associated issues are logged and tracked through to completion in the company’s complaint management system (Trackwise)
Support negotiation and authorization of contracts and other forms of purchases and procurements that are related to the company’s transportation needs. Lead local initiatives and manage the contracts in accordance
Develop important indicators (KPIs) that measure and show the effectiveness of the company’s transportation operations
Develop transportation policies across appropriate units within the organization
Support in the negotiation with third-party warehouse providers and carriers for their services and for competitive rates. Take the lead in case of a specific set-up not included in Global management
Implement management recommendations, like proposed fees and change in loading plan with the effect of CSL, inventory, cost efficiency, makes recommendations and scenarios to support the decision-making process
Cunoaste, analizeaza si monitorizeaza toate problemele tehnice care apar la nivelul sistemului de monitorizare a parametrilor HVAC, a instalatiilor de distributie azot si oxigen si a sistemelor de detectie si alarmare gaze , hotarand asupra prioritatii in ceea ce priveste interventia pe echipamente sau instalatii
Gestioneaza toate documentele aferente executiei lucrarilor contractate
Supravegheaza respectărea standardelor privind utilizarea instalaţiilor/echipamentelor pentru asigurarea condiţiilor de bune practici şi utilizării raţionale a energiei
Colaboreaza la elaborarea programului anual de intretinere si reparatii
Programeaza, in functie de programul anual de intretinere si reparatii si in functie de planul de productie de pe echipament/instalatie, derularea modului de executare a lucrarilor de intretinere, revizii si reparatii curente si capitale ale echipamentelor si instalatiilor din cadrul formatiei pe care o supervizeaza
Este responsabil cu gestionarea deseurilor rezultate din activitatea departamentului Facilitati Tehnice , in vederea respectarii procedurilor in vigoare si standardelor IS
Urmareste si furnizeaza informatii cu privire la stadiul lucrarilor repartizate
Controleaza inainte de inceperea lucrarilor, indeplinirea tuturor cerintelor stabilite de protectia muncii, prevenirea si stingerea incendiilor , protejarea mediului ambiant
To manage the strategic and tactical activities in the supply chain in all markets, and in particular: coordination of initial entry into the market of new products, management of the supply chain of products based on distribution, licensing, and brand acquisition deals as well as packaging based on contracts and service, coordination of the finalization of packaging, purchasing of API, distribution, inventory management
To ensure the successful introduction of new products and the subsequent supply of products to the markets
To support robust processes "Sales - Operations - Inventory - Planning."
To support product transfers and management activities of the supply chain
To manage demand for products from EU sources and non-EU sources/markets in order to achieve competitive costs, services, and supplies
To support the development plans of the supply chain
To build trust and camaraderie between team members
To inspire and motivate teamwork for achieving goals
To establish an open discussion for decision-making
To recognize and acknowledge the skills of key team members and utilize their strengths to the benefit of the team
To evaluate results and provide feedback in а timely fashion
Efectuează testări aferente optimizărilor & transferurilor de metode analitice, validărilor analitice și validărilor de proces, produsului MIC;
Efectuează testări de materii prime și materiale de ambalare noi;
Emite / verifică documentatie specifica (Specificații de Calitate, Protocoale și Rapoarte de transfer analitic, de validare de metode, etc.);
Emite Buletine de Analiză pentru seriile analizate;
Documentează activitatea experimentală efectuată în conformitate cu cerințele GMP / GLP;
Respectă cerințele de mediu, sănătate și siguranță în orice moment la locul de muncă, asigurând siguranță individuală, colectivă și a spațiului de lucru (laborator);
Participă la instruiri specifice interne și/sau externe.
Efectuează testări aferente optimizărilor & transferurilor de metode analitice, validărilor analitice și validărilor de proces, produsului MIC;
Efectuează testări de materii prime și materiale de ambalare noi;
Emite / verifică documentatie specifica (Specificații de Calitate, Protocoale și Rapoarte de transfer analitic, de validare de metode, etc.);
Emite Buletine de Analiză pentru seriile analizate;
Documentează activitatea experimentală efectuată în conformitate cu cerințele GMP / GLP;
Respectă cerințele de mediu, sănătate și siguranță în orice moment la locul de muncă, asigurând siguranță individuală, colectivă și a spațiului de lucru (laborator);
Participă la instruiri specifice interne și/sau externe.