Quality Alert Expert

3 days ago

Ankleshwar GJ IN Zentiva Full time

JOB DESCRIPTION Position Quality Alert Expert MANDATORY REQUIREMENTSGraduated Post-graduate in Pharmacy Medicine or Chemistry 10 to 12 years minimum experience in Quality or Regulatory Affairs Experience obtained in pharmaceutical manufacturing sites 5 years Skilled in the usage of IT tools for example Trackwise Share DrugTrack eDMS English speaker Good organizational skills stress resistance and flexibility Good Team player and good at decision-making Experience in the pharmaceutical industry with a good level of GxP know-how is a strong plus Reactivity autonomy with a sense of urgency and priorities Open-mindedness and team spirit Position Location Ankleshwar Zentiva Pvt Ltd Gujarat India ROLE SPECIFICATIONSRole Quality Expert Alert Department Quality Assurance Reports to Corporate Escalation Regulatory Surveillance Manager PURPOSE OF THE ROLETo act as quality coordinator for quality alerts investigation and further communication To act as an industrial quality focal point for quality defects and troubleshooting To act as a member of the team for the project Nitrosamine in human medicines to ensure the Authorities requests and business continuity MAIN RESPONSIBILITIES AccountabilitiesEnd-to-end coordination of quality alert issues investigation with Zentiva production sites CMO and affiliates Operational management of the quality alerts in the Zentiva QMS system Quality Forward Coordination of investigation reports compilation risk confirmation and countries notification participation in Risk meetings Regular check of the authorities websites regarding new quality alerts detection and their impact on company entities Supervising the timely execution of quality alerts in scope Support Quality Alerts Risk Management and Country Quality-related tasks based on the manager s instructions Providing a coordination role for the project Nitrosamines in human medicines work with the nitrosamine database Providing regular reporting in respective areas The employee will perform other tasks under the direction of the Manager within the agreed type of work OTHER RESPONSIBILITIES QUALITY Comply with the principles of cGxPs and Zentiva s Quality Standards in carrying out the activities of competence and regularly participate in the related training HSE Comply with the principles communicated within the framework of the Zentiva ESMS Policy specified in the Company s internal regulations for the purpose of compliance with Occupational Health and Safety regulations and the Environment and Safety Management System VIGILANCE Report adverse events and any other safety information related to ZENTIVA medicines medical devices cosmetics and dietary supplements online in the manner provided for in internal procedures COMPLIANCE Observe the Company s rules and policies Fully adhere to the principles set out in the Code of Ethics SUSTAINABILITY Adhere to the ESG principles detailed as part of Zentiva s Sustainability Strategy which is divided into 3 pillars People Partners Planet

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