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
Adaugă o evaluare și ajută-i pe alții să găsească un angajator bun.
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Administrator
Aveți informații despre mediul de lucru din această companie? Care este atmosfera? Salariul este unul motivant? Oferă și alte beneficii? Care sunt condițiile pe care le oferă? Mulțumim anticipat!
Efectueaza activitati de preparare a solutiilor de laborator, de determinare a factorului solutiilor volumetrice si de verificare a valabilitatii solutiilor de laborator, a reactivilor si a standardelor de referinta
Asigura verificarea calibrarii sticlariei de laborator
Efectueaza activitatii de analiza si prelevare (daca este cazul) a probelor de monitorizare utilitati (apa potabila, apa purificata, ultrapurificata, apa pentru preparate injectabile, azot , aer comprimat etc), cu respеctаrea principiilor GMP;
Efectuеаza verificarile/calibrarile periodice ale echipamentelor din laborator in acord cu procedurile si instructiunile de lucru interne;
Completeaza documentatia specifica activitatii de laborator;
Utilizeaza sistemul informatic LIMS in efectuarea analizelor fizico-chimice
Manipuleaza volume mari de solutii ( ≤ 5 litri – frecvent, 10 litri - moderat)
Studii postliceale (in domeniul chimiei constituie avantaj );
Studii postliceale (in domeniul chimiei constituie avantaj );
Initiere si verificare specificatii in sistemul LIMS pentru materii prime, materiale de ambalare primara, produse vrac si produse finite (fabricatie interna si testare si eliberare la nivel european)
Verificarea specificatiilor studiilor de stabilitate pentru produsul finit
Revizuirea specificatiilor tehnice de produs finit si specificatiilor tehnice de produs intermediar / vrac, in acord cu variatiile aprobate de catre autoritate si cu implementarea variatiilor ce urmeaza a fi depuse
Verificarea si evaluarea compliantei specificatiilor tehnice de produs finit in acord cu modul de lucru intern si documentatia aprobata de catre autoritati din dosarele de inregistrare pentru produsele finite fabricate intern si pentru produsele cu testare si eliberare la nivel european
Verificarea specificatiilor de materii prime si materiale de ambalare primara in acord cu documentatia aprobata din dosarul de inregistrare si FE editia curenta
Adaugarea / modificarea valabilitatii produselor vrac si produselor finite in sistemul SAP
Mentinere si actualizare prin revizii a documentatiei de calitate, gestionarea actiunilor in procesul de control al schimbarii ( Trackwise), in acord cu aprobarea variatiilor pentru produsele finite
Evaluarea compliantei produselor in acord cu dosarul aprobat la autoritati
Colaborare transversala cu departamentele QC, AD, ITT, RA si QA in vederea alinierii documentatiei de calitate, in acord cu aprobarile autoritatii, cerintele interne si GXP
Verificarea datelor de regualtory referitoare la produs in sistemele informatice specifice RA – eDMS , SHARE, VISTA
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