Bucureşti Sectorul 2, Str. DOMNITA RUXANDRA, Nr. 12, Etaj P, Apartament CAMERA A
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Analiza materiilor prime, materialelor de ambalare si a produselor finite
Dezvoltarea si validarea metodelor analitice ( HPLC; GC; IR; UV; KF), de determinare a substantelor active si impuritatilor, pentru controlul de calitate si „cleaning” al produselor Sindan Pharma
Efectuarea de teste si analize fizico-chimice pentru dezvoltarea farmaceutica a produselor Sindan Pharma: analiza seriilor de laborator, teste de stabilitate in conditii accelerate si in timp real
Efectuarea de studii analitice ( fotostabilitate ,stabilitate in-use, inghet-dezghet, studii de transport)
Cunoasterea si respectarea Procedurilor de Operare Standard in conformitate cu GMP
Semnalarea necesitatii achizitionarii de reactivi, solutii titrate, coloane cromatografice, substante de referinta, accesorii de laborator, sticlarie si alte materiale necesare desfasurarii unei activitati continue in laborator
Analist Chimist Controlul Calitatii, Sindan Pharma
București
expirat: 25.11.2022
Middle (2-5 ani), Entry (0-2 ani)
Anunțuri Arhivate
Anunțuri Arhivate
Supervizor productie - Sindan Pharma
București
expirat: 25.11.2022
Middle (2-5 ani), Entry (0-2 ani)
Anunțuri Arhivate
Anunțuri Arhivate
Operator Productie Farmaceutica, Sindan Pharma
București
expirat: 25.11.2022
Middle (2-5 ani), Entry (0-2 ani)
Anunțuri Arhivate
Anunțuri Arhivate
Chimist Cercetare Dezvoltare (Temporar)
București
expirat: 31.10.2022
Middle (2-5 ani), Entry (0-2 ani)
Salariu confidențial
Anunțuri Arhivate
Anunțuri Arhivate
Specialist Quality (Temporary), Sindan Pharma
București
expirat: 31.10.2022
Middle (2-5 ani)
Salariu confidențial
Anunțuri Arhivate
Anunțuri Arhivate
Sr PV Professional, Process Excellence (18 months)
București
expirat: 31.10.2022
Middle (2-5 ani)
Salariu confidențial
Anunțuri Arhivate
Anunțuri Arhivate
Analist Chimist Controlul Calitatii, Sindan Pharma
București
expirat: 21.10.2022
Middle (2-5 ani), Entry (0-2 ani)
Salariu confidențial
Anunțuri Arhivate
Anunțuri Arhivate
Operator Productie Farmaceutica, Sindan Pharma
București
expirat: 16.10.2022
Middle (2-5 ani), Entry (0-2 ani)
Salariu confidențial
Anunțuri Arhivate
Anunțuri Arhivate
Supervizor productie - Sindan Pharma
Odăile
expirat: 09.10.2022
Middle (2-5 ani), Entry (0-2 ani)
Salariu confidențial
Anunțuri Arhivate
Anunțuri Arhivate
Analist Chimist Controlul Calitatii, Sindan Pharma
București
expirat: 17.07.2022
Entry (0-2 ani), Middle (2-5 ani)
Salariu confidențial
Anunțuri Arhivate
Anunțuri Arhivate
Chimist Cercetare Dezvoltare (Temporar)
Odăile
expirat: 17.07.2022
Entry (0-2 ani), Middle (2-5 ani)
Atribuțiile:
Analiza materiilor prime, materialelor de ambalare si a produselor finite
Dezvoltarea si validarea metodelor analitice ( HPLC; GC; IR; UV; KF), de determinare a substantelor active si impuritatilor, pentru controlul de calitate si „cleaning” al produselor Sindan Pharma
Efectuarea de teste si analize fizico-chimice pentru dezvoltarea farmaceutica a produselor Sindan Pharma: analiza seriilor de laborator, teste de stabilitate in conditii accelerate si in timp real
Efectuarea de studii analitice ( fotostabilitate ,stabilitate in-use, inghet-dezghet, studii de transport)
Cunoasterea si respectarea Procedurilor de Operare Standard in conformitate cu GMP
Semnalarea necesitatii achizitionarii de reactivi, solutii titrate, coloane cromatografice, substante de referinta, accesorii de laborator, sticlarie si alte materiale necesare desfasurarii unei activitati continue in laborator
Analist Chimist Controlul Calitatii, Sindan Pharma
București
expirat: 31.05.2022
Entry (0-2 ani), Middle (2-5 ani)
Salariu confidențial
Anunțuri Arhivate
Anunțuri Arhivate
QA IT junior
București
expirat: 31.05.2022
Entry (0-2 ani), Middle (2-5 ani)
Salariu confidențial
Anunțuri Arhivate
Anunțuri Arhivate
Associate Regulatory Affairs
București
expirat: 01.05.2022
Entry (0-2 ani), Middle (2-5 ani)
Atribuțiile:
Collect and evaluate data for inclusion in marketing authorization dossiers (Module 3)
Compile dossiers (Module 3 and corresponding QoS) for presentation to regulatory authorities or clients, taking all necessary measures to ensure that dossiers meet relevant, current requirements while not being overly restrictive.
Respond to queries (from regulatory authorities or clients) concerning dossiers submission or changes. Manage the process to respond to the CMC questions by involving all stakeholders both within and outside the company and following up agreed actions in order to respond as rapidly and completely as possible
Prepare the variation and post-approval change packages and other necessary documents as required by the regulatory post-approval processes
Maintain the dossier (Module 3 and corresponding QoS) fully up to date during registration procedures and as a consequence of a variation or of a site transfer
Participation in transfer activities and related coordination of technology transfer
Introduction of new technologies and equipment’s in accordance with MS&T standards
Participation in the process of continuously increasing robustness
Perform day-to-day process validation, continue process verification, cleaning validation, media fill process maintenance & operational tasks and ensures appropriate service levels are developed and monitored
Collect and evaluate data for inclusion in marketing authorization dossiers (Module 3)
Compile dossiers (Module 3 and corresponding QoS) for presentation to regulatory authorities or clients, taking all necessary measures to ensure that dossiers meet relevant, current requirements while not being overly restrictive
Respond to queries (from regulatory authorities or clients) concerning dossiers submission or changes. Manage the process to respond to the CMC questions by involving all stakeholders both within and outside the company and following up agreed actions in order to respond as rapidly and completely as possible
Prepare the variation and post-approval change packages and other necessary documents as required by the regulatory post-approval processes
Assist in the collection and evaluation of data for inclusion in marketing authorization dossiers
Prepare the variation and post-approval change packages and other necessary documents as required by the variation process
Manage the process to respond to the CMC questions by involving all stakeholders and following up agreed actions in order to respond as rapidly and completely as possible
Assist in keeping the dossier (Module 3 and corresponding QoS) fully up to date during registration procedures and as a consequence of a variation or of a site transfer
Respond to queries (from regulatory authorities or clients) concerning potential changes
Ensure that the documentation of the Active Substance Master Files is appropriate for the required purpose and targeted countries
Review for regulatory compliance the Stability protocol and compile raw data
Participate in meetings related to registration procedures or when the CMC expertise is needed
Review regulatory compliance protocols and/or reports, as requested
Assist in the collection and evaluation of data for inclusion in marketing authorization dossiers
Prepare the variation and post-approval change packages and other necessary documents as required by the variation process
Respond to queries (from regulatory authorities or clients) concerning dossiers, manage the process to respond to the CMC questions by involving all stakeholders both within and outside the company and following up agreed actions in order to respond as rapidly and completely as possible
Preparation of monthly P&L both on detailed and high level, in accordance with companys requirements;
Perform monthly analysis between Actuals and Budgeted numbers (Sales/Expense) and explain variations;
Review/Analyze monthly numbers and check for accuracy of bookings;
Assists Finance Director in preparation of Annual Operating Plan (AOP) and all other Business Estimates (LBE) required by the group;
Prepares annual and quarterly submission files, in accordance with the instructions and verifies the completness of the information submited;
Assists management team in preparation of the required financial related information for internal/external presentations;
Prepares various financial reports (detailed level/consolidated) requested by direct manager or any other persons from the business in accordance with the instructions received;
Provide requested information to internal/external auditors;
Update of Chart of Accounts and cost centers, in accordance with internal/external requirements;
Preparation of monthly P&L both on detailed and high level, in accordance with companys requirements;
Perform monthly analysis between Actuals and Budgeted numbers (Sales/Expense) and explain variations;
Review/Analyze monthly numbers and check for accuracy of bookings;
Assists Finance Director in preparation of Annual Operating Plan (AOP) and all other Business Estimates (LBE) required by the group;
Prepares annual and quarterly submission files, in accordance with the instructions and verifies the completness of the information submited;
Assists management team in preparation of the required financial related information for internal/external presentations;
Prepares various financial reports (detailed level/consolidated) requested by direct manager or any other persons from the business in accordance with the instructions received;
Provide requested information to internal/external auditors;
Update of Chart of Accounts and cost centers, in accordance with internal/external requirements;
Preparation of Monthly P&L both on detailed and high level, in accordance with Companys requirements;
Perform monthtly analysis between Actuals and Budgeted numbers (Sales/Expense) and explain variations;
Review/Analyze monthly numbers and check for accuracy of bookings;
Assists Finance Director in preparation of Annual Operating Plan (AOP) and all other Business Estimates (LBE) required by the group;
Prepares annual and quarterly submission files, in accordance with the instructions and verifies the completness of the information submited;
Assists management team in preparation of the required financial related information for internal/external presentations;
Prepares various financial reports (detailed level/consolidated) requested by direct manager or any other persons from the business in accordance with the instructions received;
Provide requested information to internal/external auditors;
Update of Chart of Accounts and cost centers, in accordance with internal/external requirements;
Assist in the collection and evaluation of data for inclusion in marketing authorization dossiers
Prepare the variation and post-approval change packages and other necessary documents as required by the variation process
Respond to queries (from regulatory authorities or clients) concerning dossiers, manage the process to respond to the CMC questions by involving all stakeholders both within and outside the company and following up agreed actions in order to respond as rapidly and completely as possible