Candidatul Ideal
Bachelor's degree in pharmacy and chemistry;
Experience: 2 to 5 years in QMS and documentation. CMO management experience will be added advantage;
Knowledge of quality policies, quality assurance systems and GxP concepts;
Knowledge in the field of pharmaceutical industry: manufacture of medicines, packaging, quality assurance, quality control and storage operations;
Knowledge regarding the installations, machines and equipment of measurement and control used in the pharmaceutical industry, as well as about their proper maintenance;
Knowledge regarding the characteristics of the substances used or resulted from the technological processes, used in quality control, which may have a harmful effect on the personnel;
PC operating knowledge;
Knowledge of the SSM, Environment and US standards specific to the pharmaceutical industry;
Abilities:
• Professionalism;
• Ability to plan and organize the activity;
• Communication, analysis and interpretation skills of data;
• Fairness, honesty, confidentiality;
• Ability to work with people, evaluate and make decisions;
• Capacity for analysis, synthesis, research and investigation;
• Concentrated and distributive attention;
• Classification and interpretation of information;
Experience: 2 to 5 years in QMS and documentation. CMO management experience will be added advantage;
Knowledge of quality policies, quality assurance systems and GxP concepts;
Knowledge in the field of pharmaceutical industry: manufacture of medicines, packaging, quality assurance, quality control and storage operations;
Knowledge regarding the installations, machines and equipment of measurement and control used in the pharmaceutical industry, as well as about their proper maintenance;
Knowledge regarding the characteristics of the substances used or resulted from the technological processes, used in quality control, which may have a harmful effect on the personnel;
PC operating knowledge;
Knowledge of the SSM, Environment and US standards specific to the pharmaceutical industry;
Abilities:
• Professionalism;
• Ability to plan and organize the activity;
• Communication, analysis and interpretation skills of data;
• Fairness, honesty, confidentiality;
• Ability to work with people, evaluate and make decisions;
• Capacity for analysis, synthesis, research and investigation;
• Concentrated and distributive attention;
• Classification and interpretation of information;
Descrierea jobului
Responsibilities:
Responsible for handling the existing CMOs & CSPs to maintain the qualification status up to date;
Responsible for handling the new CMOs & CSPs, to ensure the qualification is completed before launching the new product;
Responsible for managing of Technical Agreements (periodical TAs review and new TAs);
Responsible to manage the QMS notifications received from CMOs and QMS items initiated locally related to CMO / CSP (change control, deviations, complaint investigation etc.);
Responsible for monthly monitoring of CMOs KPIs;
Responsible for managing the implementation of Global SOPs relating to CMO /CSP;
Responsible to provide support to lead auditor for audits handling and follow up (qualification and routine audits);
Responsible to ensure the implementation by CMO of any Regulatory requirements;
Responsible for handling the existing CMOs & CSPs to maintain the qualification status up to date;
Responsible for handling the new CMOs & CSPs, to ensure the qualification is completed before launching the new product;
Responsible for managing of Technical Agreements (periodical TAs review and new TAs);
Responsible to manage the QMS notifications received from CMOs and QMS items initiated locally related to CMO / CSP (change control, deviations, complaint investigation etc.);
Responsible for monthly monitoring of CMOs KPIs;
Responsible for managing the implementation of Global SOPs relating to CMO /CSP;
Responsible to provide support to lead auditor for audits handling and follow up (qualification and routine audits);
Responsible to ensure the implementation by CMO of any Regulatory requirements;
Descrierea companiei
Terapia - a SUN PHARMA Company este cea mai mare companie de medicamente generice din Romania. Sun Pharma este a cincea cea mai mare companie de produse generice și specializate din lume și prima companie farmaceutică din India, cu o prezență globală în 65 de piețe și produse comercializate în peste 150 de țări.
Compania ofera un portofoliu solid și extins de produse generice și specializate, aducând beneficii pacienților din întreaga lume. În același timp, Sun Pharma se remarca prin resursele ei multiple, tehnologia avansată și capacitățile de producție de ultimă generație.
Doresti sa-ti construiesti o cariera intr-o companie unde gasesti mediul cel mai potrivit pentru dezvoltarea ta si unde poti intalni toate ingredientele care sunt importante pentru tine ca sa fii multumit si implinit pe plan profesionala? Alege PROVOCAREA, alatura-te echipei Terapia - a SUN PHARMA Company, iar noi te asiguram de suportul nostru continuu pentru dezvoltarea ta ulterioara!
www.sunpharma.com
Compania ofera un portofoliu solid și extins de produse generice și specializate, aducând beneficii pacienților din întreaga lume. În același timp, Sun Pharma se remarca prin resursele ei multiple, tehnologia avansată și capacitățile de producție de ultimă generație.
Doresti sa-ti construiesti o cariera intr-o companie unde gasesti mediul cel mai potrivit pentru dezvoltarea ta si unde poti intalni toate ingredientele care sunt importante pentru tine ca sa fii multumit si implinit pe plan profesionala? Alege PROVOCAREA, alatura-te echipei Terapia - a SUN PHARMA Company, iar noi te asiguram de suportul nostru continuu pentru dezvoltarea ta ulterioara!
www.sunpharma.com
