Quality Alert Expert

4 days ago

Ankleshwar, India Zentiva Group, a.s. Full time

Position: Quality Alert Expert MANDATORY REQUIREMENTS - Graduated / 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 SPECIFICATIONS - Role: Quality Expert Alert - Department: Quality Assurance - Reports to: Corporate Escalation & Regulatory Surveillance Manager PURPOSE OF THE ROLE - To 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 & Accountabilities - End-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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